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Location: San Diego, CA
Duration: 9 Months
Job Description:
The Build & Integration Engineer will be responsible for supporting global engineering teams and client's customers in resolving build, integration, and functional issues across multiple operating systems and platforms. This role requires strong system-level understanding, hands?on debugging expertise, and the ability to collaborate across diverse technical teams. The engineer will work closely with internal and external stakeholders to triage issues, enhance integration workflows, and contribute to automation and tooling improvements for increased efficiency.
Responsibilities:
- Establish and maintain effective working relationships with peers associated with system integration of BSP and Multimedia environment.
- Work on toolchain and system integration of RTOS functionalities.
- Communicate with source and consumer environment stakeholders to ensure seamless integration between various environments during design, development, testing and deployment phases.
- Work with team leads and project leads to provide support and contribution in preparing critical customer User Acceptance scenarios.
- Assist in deploying and migrating project artifacts within the production environment and customer development sites.
- Maintain and monitor jobs and programs in production as well as provide issue resolution for any production failures. Assist and provide guidance to resolve system-related issues.
- Develop, modify and debug automation programs with CI/CD environments
- Develop and deploy tools and technologies to optimize the build times for faster deployment.
Required:
- 2+ years of academic or work experience with Programming Language Python, etc.
- 5+ years of experience developing tools using Python that is used smart integration and release of software to external developers
- Experience with software configuration management tools (e.g., Git/Gerrit), integration, build environments, and debug aids (e.g., Trace 32).
- Experience with Linux Bash Shell
- Excellent Communication skills and self-starter.
- 5+ years of experience with makefiles, bitbake using C/C++ on Yocto Linux, Android, and RTOSs on ARM-based platforms (QNX).
Education:
- Bachelor's Degree in Engineering, Information Systems, Computer Science or related field and 2+ years of Software Engineering or related work experience OR Master's Degree in Engineering, Information Systems, Computer Science or related field and 1+ year of Software Engineering or related work experience OR PhD in Engineering, Information Systems, Computer Science or related field
Immediate need for a talented R&D Project Manager. This is a 12+ months contract opportunity with long-term potential and is located in San Diego, CA(Hybrid). Please review the job description below and contact me ASAP if you are interested.
Job ID:26-08555
Pay Range: $60 - $90/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Lead and manage multiple R&D programs and/or large-scale product development projects, from feasibility through commercialization, including Class II and/or Class III medical devices (with emphasis on electrically active/medical electrical equipment where applicable).
- Develop and maintain integrated program plans, timelines (Gantt charts), budgets, resource plans, and risk registers; proactively identify and mitigate risks across technical, regulatory, clinical, commercial, and electrical safety dimensions.
- Define project scope, objectives, deliverables, and success criteria; create and maintain project charters, work breakdown structures (WBS), and detailed schedules.
- Lead cross-functional core teams (R&D/Engineering, Quality, Regulatory Affairs, Clinical, Manufacturing, Marketing, and Operations) to execute program objectives; facilitate effective decision-making and resolve conflicts.
- Drive adherence to Design Control processes (21 CFR 820.30), risk management (ISO 14971), usability engineering (IEC 62366), basic safety and essential performance requirements for medical electrical equipment (IEC 60601-1 series), and other applicable standards throughout the product lifecycle.
- Provide regular status updates, executive-level reporting, and dashboards to senior leadership and stakeholders; communicate program progress, issues, decisions, and changes clearly and proactively.
- Support regulatory strategy development and submissions (e.g., 510(k), PMA, technical files for CE marking), including coordination of electrical safety testing, EMC compliance (IEC 60601-1-2), and collateral/particular standards as needed.
- Foster a collaborative, innovative, and compliant culture within program teams.
- Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and cross functional teams management.
- Lead cross-functional teams through identification of risks & mitigations, problem resolution and root cause analysis, corrective and preventive action.
- Develop and maintain integrated project plan with risk-based timeline, critical path milestones, resource allocation, roadmap with clear milestones for gap analysis, risk management, remediation, testing, certification and budget tracking to support certification goals
- Monitor the effectiveness and performance of the launch and project team and facilitate the development of contingency plans, recommending corrective actions as required.
- Ensure compliance with quality management systems and regulatory requirements, where applicable.
- Lead the team to prepare for and execute Phase Gate. Represent the team with Client leaders, ensuring such decisions are informed by a balanced and clearly articulated representation of the relevant data.
- Leverage technical acumen to partner with engineering teams, monitor development progress, and ensure alignment between technical deliverables and program timelines
- Drive design control discipline throughout product development, ensuring compliance
- Conduct or oversee gap assessments against general, collateral, and particular standards for medical electrical equipment safety and essential performance.
- Manage integrated risk management (per ISO 14971), including essential performance definition, hazard analysis, risk controls, and verification.
- Coordinate and manager the execution of test plans for electrical safety, EMC, mechanical, environmental, and essential performance requirements; coordinate pre-compliance and formal third-party testing.
- Oversee compliance documentation: technical files, risk management files, test reports, essential performance rationale, and certification justification.
- Integrate compliance activities with the quality management system (ISO 13485) and other regulatory requirements (FDA, EU MDR, etc.).
- Serve as primary liaison with notified bodies, test labs, and regulatory consultants to support certification and post-compliance needs.
- Drive a safety-focused culture while ensuring the team meets the September 2027 compliance target
Key Requirements and Technology Experience:
- Key Skills;Bachelor’s degree in Engineering (Biomedical, Electrical, Mechanical, or related),Life Sciences, or equivalent.
- 3-5 years of project management in medical devices, with ≥5 years leading compliance programs for medical electrical equipment.
- Proven track record of successfully delivering medical device programs from concept to market launch (including regulatory clearance/approval).
- Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971 risk management, IEC 62304 (software), and global regulatory pathways (510(k), De Novo, PMA, MDR).
- Proficiency with project management tools (e.g., MS Project, Jira, Smartsheet, or similar) and standard office software.
- Project Management Professional (PMP) certification not required but is preferred
- Scrum Master and SAFE Agile certification is preferred.
- Experience in medical device industries required, including experience in FDA or other regulated environments.
- Knowledge of the medical device industries beneficial integrating science and technology into business processes.
- Technical background in electrical, mechanical, or biomedical engineering
- Expert in the development and deployment of program management tools and techniques including methods for tracking progress, risk management and delivery of major milestones.
- Understanding of engineering development lifecycles and the ability to translate technical inputs into program-level actions and timelines
- Excellent influencing skills with the ability to achieve challenging goals through others without direct authority across different functions, external partners, geographies, and cultures.
- Drive for accountability within self and others.
- Proven project management experience with delivering medium-to large-scale projects in managed service model from concept through delivery and operations
- Relentless advocacy for the customer with a focus on meeting or exceeding customer requirements.
- Driving the team to make trade-offs that optimize customer and business value while maintaining program velocity and outcomes that sustain the highest standards of quality.
- Direct experience with major test labs and certification bodies for medical electrical equipment standards.
- Experience with programmable electrical medical systems (PEMS) or software-inclusive devices (IEC 62304 knowledge a plus)
- Proven success taking Class II (or higher) active medical electrical devices from gap assessment through third-party certification.
- Strong knowledge of ISO 14971, ISO 13485, general/collateral/particular standards for medical electrical safety and essential performance, and EMC requirements.
- Familiarity with FDA QSR (21 CFR Part 820), EU MDR/IVDR, or other global regulations.
Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.
Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations.
Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.
Visit us at to learn more and view our open positions.
Please apply or call one of us to learn more For further inquiries regarding the following opportunity, please contact our Talent Specialist, Lavanya at (224) 369-0873 Title: Cybersecurity Specialist Duration: 6 Months with a strong possibility of extension or full-time Location: St.
Paul, MN or Abbott Park (North Chicago) Travel: Very limited, possibly 1 2 times during the 6 month period, likely none.
Work Schedule: 8 hours/day, 5 days/week Only W2 candidates are eligible for this position.
Third-party or C2C candidates will not be considered Role Overview The role has a strong focus on medical devices, IoT/sensor-based products, mobile applications, and backend systems, including building security standards, guidance, dashboards, and validating the effectiveness of cybersecurity controls.
Description: As a Senior Cyber Specialist Digital Enablement, you will play an important role in ensuring that Client product technologies leveraged by healthcare providers and consumers are secure-by-design.
These technologies range from regulated medical devices to e-commerce and customer loyalty solutions.
You will evaluate the cybersecurity posture of new and existing product technologies, identify risks, recommend mitigation strategies, and ensure timely remediation and closure.
You will bring deep expertise in security risks, controls, mitigations, and global cybersecurity standards to Client product teams.
This role is expert-driven and guidance-focused, requiring strong technical depth, excellent communication skills, and a proven ability to navigate a large, global environment.
You will partner closely with internal product owners, developers, engineers, security architects, and external collaborators to evaluate solutions, strengthen governance, and guide secure product development.
Your work will directly contribute to the delivery of scalable, compliant, and secure product technologies, cloud services, and connected applications.
The role focuses on consultative responsibilities rather than hands on development or cybersecurity operations.
Primary Responsibilities Develop and maintain security guidance documentation, including standards and frameworks Conduct full-stack architecture reviews of products and platforms, including consumer identity platforms Perform cybersecurity threat modeling and prepare outputs for review by internal and external stakeholders Establish, document, and monitor compliance with risk based and regulatory-informed cybersecurity requirements for individual products Collaborate with product designers and developers to ensure security considerations are integrated early into product design discussions Validate the security of product software supply chains and product deployment pipelines Develop risk mitigation strategies and recommend appropriate security controls Assess and prioritize product security risks through detailed evaluation of vulnerability assessments and penetration testing results Evaluate the effectiveness of product cybersecurity controls Identify and effectively communicate cyber risk trends Ensure risk management plans are clearly documented, actionable, and accurately reflect the organization's risk tolerance Track and ensure product compliance with defined vulnerability remediation SLAs.
Participate in governance forums, architecture reviews, and technical discussions as a representative of Product Cybersecurity Required: At least 5 years of experience but typically 7 plus years of experience is required.
Possess expertise in valuing and implementing industry standards such as the ISO 27001/2, SOC 2, HITRUST and FedRAMP Information Security standard and the ISO 22301 Business Continuity Standard.
Experience with implementation and operational use of GRC toolsets (Governance Risk and Compliance).
Possess CISSP certification (or similar) and be knowledge of national and international regulatory compliances and frameworks such as ISO, SOX, BASEL II, EU DPD, HIPAA, and PCI DSS.
Ability to influence policy/standards for emerging tech (AI, quantum, cloud).
About You 7 years of experience in cybersecurity or technology architecture, assessment, or consulting with a focus on the development of secure digital product technologies Experience conducting risk assessments, control assessments, and governance reporting Ability to clearly articulate cybersecurity risks and recommended mitigations to product development teams Strong understanding of modern technology stacks, including cloud native architectures and API-driven services Understanding of core concepts related to identity and access management, secure software development, network security, and cryptography Familiar with device to device, service to service, and consumer identity and access management practices Familiarity with modern phishing-resistant authentication technologies, including WebAuthn and Passkeys Understanding of cybersecurity risks associated with emerging technologies, including quantum computing and artificial intelligence Knowledge of global medical device regulatory frameworks Excellent analytical, problem-solving, and communication skills Working knowledge of security frameworks and standards (e.g., NIST, ISO/IEC 27001, PCI DSS) Strong collaboration and influencing skills, with the ability to work effectively across technical and business teams Exceptional written and verbal communication skills, with the ability to tailor complex information for diverse audiences Strong analytical and problem solving skills, with the ability to work independently and manage multiple priorities Bachelor's degree in Cybersecurity, Computer Science, Information Systems, Information Assurance, Software Engineering, or a related field but not mandatory if experience is strong Preferred Qualifications Strong preference for candidates with cybersecurity experience across e commerce, mobile apps, IoT, or medical devices.
Preferred certifications include CISSP, HCISPP, CISM, CCSP, SABSA Foundation, CISA, or similar industry-recognized certifications Background in application security, product security, and secure development practices.
Experience supporting mobile applications, sensors, and backend operational systems.
Ability to draft, influence, and operationalize cybersecurity policies and standards.
Reading Static Application Security Testing (SAST)/Dynamic Application Security Testing (DAST) outputs, pen test results; collaborating with teams; no major required internal tools.
Top 3 required skills: Cybersecurity consulting w/ development teams (software/hardware).
Ability to influence policy/standards for emerging tech (AI, quantum, cloud).
Ability to evaluate the effectiveness of cybersecurity controls.
Top 3 preferred skills: Medical device or IoT cybersecurity; development background; broader product security experience.
Certifications: Not required; experience is prioritized over certs.
Industry experience: Medical device preferred; e commerce, IoT, cloud, and mobile app security also acceptable.
Systems used daily: Reading Static Application Security Testing (SAST)/Dynamic Application Security Testing (DAST) outputs, pen test results; collaborating with teams; no major required internal tools.
Personality traits: Curious, detail oriented, collaborative, strong communication, relationship builder.
Interview Process: One Teams Video interview About us: DivIHN, the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond.
The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer.
DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.
SOX, ISO, HIPAA, HITRUST, SOC 2, ISO 27001/2, BASEL II, EU DPD
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Description
At American Packaging Corporation (APC), you'll find the packaging career you've been looking for. With competitive salaries, excellent benefits, 401(k) plans and tuition reimbursement programs, we nurture our employees while advancing and promoting diversity and inclusion. As the leading flexible packaging converter in North America for over a century, APC's longstanding success is fueled from the inside out. We're constantly seeking to improve our internal operations and were named a "Best of the Best" in the Best workplaces in the America's awards for 12 years in a row. It's how and why we engage the best and brightest talent to continue propelling our shared success into the future.
LOCATION: Story City, IA
SUMMARY: We are seeking a motivated Product Development Engineering Intern to support our engineering teams in developing and optimizing flexible packaging solutions. This role provides hands-on experience with material selection, packaging design, testing, and process improvement in a manufacturing environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
* Participate in training, embrace concepts of and actively practice the STOP Safety Program fundamentals to aid American Packaging Corporation's efforts to achieve a zero accident rate.
* Familiarity with the principles and requirements of ISO 9000, ISO 14001, AIB, and SQF.
* Qualify new and alternate materials.
* Monitor Quality Assurance system to ensure that current procedures/testing correlate with customer requirements.
* Update system/procedures as required and develop appropriate procedures to complete assigned projects.
* Manage in-plant trials through conducting pre-trial planning meetings, directing on-line manufacture of trial materials, documenting results of trials and ensuring trial results are met.
* Attend and participate in all company mandated meetings.
* Other duties as assigned.
Requirements
QUALIFICATION REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Pursuing a Bachelor's degree in Packaging Science.
Experience with lab equipment such as tensile tester, heat sealer, etc.
Experience with Microsoft Excel
Ability to gather data competently into a report format
Statistical Experience is optional
LANGUAGE SKILLS
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
MATHEMATICAL SKILLS
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
REASONING ABILITY
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
PHYSICAL DEMANDS
The physical demands described here are representatives of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel and talk or hear. The employee frequently is required to sit and reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 10 pounds.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
American Packaging Corporation is committed to equal opportunity for all, without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. American Packaging Corporation will make reasonable accommodations for known physical or mental limitations of otherwise qualified employees and applicants with disabilities unless the accommodation would impose an undue hardship on the operation of our business. EOE/AA Disability/Veteran.
If you are interested in applying for an employment opportunity and need special assistance or an accommodation to apply for a posted position, please contact our Human Resources department at:
.
Work Location: 1915 Hurd Drive, Irving, TX, USA, 75038
Assignment Duration: 12 months
Work Schedule: Monday-Friday, 6:00 AM - 2:30 PM (Training Schedule: 8:45 to 3:30 Monday 7:00 to 3:30 Tuesday; 6:00am to 2:30 next 8 days)
Work Arrangement: Onsite
Job Summary:
Working under general supervision, this position is responsible for the production of high-quality medical device instruments. This position includes detailed assembly and testing of various electronic components and finished devices in a controlled manufacturing environment.
Job Responsibilities:
* Performs testing of electronic components and assemblies using automated test equipment
* May perform mechanical assembly of electromechanical subassemblies and devices
* Ability to read, comprehend and follow written procedures; understand and follow verbal instructions. May instruct others in the use of all manuals, test procedures and documentation associated with specialized equipment.
* Reads and interprets engineering drawings, schematics and complex test procedures.
* Participates in continuous improvement/quality initiatives in order to enhance production processes to achieve quality and profitability metrics.
* Maintains accurate records to ensure Device History Records and quality documents are accurate, all parts are traceable and quality issues can be addressed to assure the quality of all products.
* Prioritizes work by determining the sequencing and timing of different jobs based on precedence and importance.
* Positively represents the company during tours by demonstrating techniques and sharing appropriate information.
* Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
* Complies with U.S. Food and Drug Administration (FDA) regulations, ISO or other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
* Adheres to all environmental, health and safety SOP's, equipment, policies and procedures, including any department specific requirements.
* Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Minimum Qualifications:
* Experience with electronic assembly and test in a medical device industry preferred.
* High School Diploma or equivalency is required, preferred AAS
* 2 or more years experience with electromechanical assemblies/electronic manufacturing, technical certifications, etc. preferred
Preferred Qualifications:
* Experience in troubleshooting equipment, building and or testing of electronic assemblies
* Working knowledge of IPC standards and use of complex tools and equipment specific to functional areas
* Experience in GMP, ISO, and FDA controlled environments preferred
* Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
* Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
* Multitasks, prioritizes and meets deadlines in timely manner.
* Strong organizational and follow-up skills, as well as attention to detail.
* Ability to maintain regular and predictable attendance.
* Ability to work scheduled overtime as required is preferred.
* Ability to hand and lift up to 25 lbs. as needed for specific job functions
* Must be able to sit and/or stand for long periods of time.
* Ability to frequently sit, stand, walk, reach within hands and arm's length, stoop, kneel and crouch.
Title: Compliance Analyst III
Location: Indianapolis, IN 46214
Duration: 6 Months (Contract-to-Hire)
Shift Timing: 1st Shift | 8:00 AM to 5:00 PM Mon-Fri
Payrate: $43.26/hr
Job Summary:
- We are seeking a highly skilled, experienced Senior QA Compliance Auditor to join our team on a contract-to-hire basis.
- This role supports clinical research drug development, offering commercial diagnostic laboratory testing services within a highly regulated setting.
- The ideal candidate will bring deep expertise with an action-oriented mindset and the ability to lead challenging audit activities across the global enterprise to ensure operational compliance to GCP, GCLP, ISO 13485, ISO 15189, CAP/CLIA regulations and industry standards.
Key Responsibilities:
Audit Planning, Execution & Oversight
- Plan, schedule, and conduct audits across the clinical laboratory, and operational support functions.
- Host and support sponsor-client audits and regulatory inspections
- Perform external audits of suppliers and service providers.
- Support audit response development and CAPA implementation, ensuring responsiveness and delivery requirements are met for client and business stakeholders.
Compliance Monitoring & Issue Resolution
- Evaluate adherence to SOPs, regulatory requirements, and industry standards.
- Lead the response process for audits and inspections, including CAPA development, implementation and tracking.
- Monitor and drive closure of audit-related deliverables, ensuring timely completion and effectiveness.
- Support global QA policy implementation and interpretation of regulatory requirements.
- Ensure compliance with applicable regulations (GCP, ISO 15189, CAP, etc.) and internal quality standards.
- Participate in global quality initiatives to improve compliance and operational efficiency.
Training & Continuous Improvement
- Develop, deliver and participate in training on audit practices and compliance expectations.
- Promote a culture of quality and continuous improvement across teams.
Documentation & Reporting
- Prepare detailed audit reports with actionable recommendations.
- Track and report quality metrics, identifying trends and areas for improvement.
- Maintain audit records and ensure inspection readiness.
Education:
- Bachelor’s degree in life sciences or related field; advanced degree preferred.
- Equivalent experience may be considered in lieu of advanced education requirements .
Experience:
- Minimum 6 years in a regulatory or GxP-compliant environment.
- Proven experience with quality systems and regulatory inspections.
- Strong understanding of ISO 15189, ISO 13485, and risk-based auditing methodologies.
Skills:
- Strong communication, organizational, negotiation, and problem-solving skills.
- Ability to influence cross-functional teams and drive compliance initiatives.
- Success-oriented in working both independently and in dynamic team environments.
- Proficiency with quality management system applications and/or platforms (e.g., Veeva, TrackWise) is a plus.
Certifications (Preferred):
- ASQ Certified Quality Auditor (CQA)
- ASQ Certified Quality Manager or Quality Engineer (CQM/CQE)
- SQA Registered Quality Assurance Professional (RQAP)
Required Skills:
- Highly organized.
- Computer literacy skills.
- Exp with ISO 15189 or ISO13485.
Additional Information:
- Travel: Occasional regional travel (5%) may be required.
Fundada en 1985, ATS es una empresa con presencia en los Estados Unidos, México y el Reino Unido. Somos profesionales en mantenimiento industrial y hacemos que las fábricas funcionen mejor.
Summary:
The Condition Monitoring Expert II will remotely monitor machine health and coordinate the distribution of gathered information to ensure machines are operating properly to increase productivity and reduce risk. They will serve as the secondary resource for support to include monitoring and research of complex service alerts and other machine information while coordinating with customers or location personnel to provide solutions.
Principal Duties/Responsibilities:
- Performs data analysis, report generation, and technical consultation using technologies such as ultrasound assessments, vibration analysis, and oil analysis, and other contextual data collected from remote sensor applications.
- Uses data analysis tools to identify impactful asset risks, and influence customer maintenance teams to leverage opportunities to reduce machine downtime, reactive labor, and failures.
- Evaluates machine information, technical data, and component specification to provide asset focused proactive corrective actions to customers.
- Analyzes data to determine trend changes, and probable causation to provide feedback and recommended corrective actions to preempt failures and prevent downtime/reduce cost.
- Utilizes remotely gathered sensor data to detect, identify, and isolate specific component degradation and its causes prior to serious damage or actual failure.
- Leads ongoing cadence calls, responds to incoming and escalated technical inquiries from customers via telephone and platform communication venues, and escalates to Senior level Condition Monitoring Experts for support in higher complexity analysis and communications.
- Serves as a secondary triage for incoming customer inquiries and handles or escalates appropriately.
- Effectively presents information to management and customers through creation of asset health reports, critical technical findings, and root cause documentation.
- Communicates summaries of actionable recommendations quickly and accurately through translation of technical, statistical, and predictive data analytics into front-line action planning.
- Connects directly with customer front-line technicians to guide troubleshooting, supporting data collection, and provision of OJT support in corrective actions.
- Reviews installation of devices, validation of data accuracy, and provides initial insights from newly monitored equipment in the completion of the condition monitoring program "first-pass".
- Participates in customer facing training and consultation with emphasis on technical elements of monitoring data interpretation and corrective actions.
- Provides excellent customer service and follow-up through ad-hoc and regularly scheduled customer meetings.
- Assists customers in calculation of cost savings and identification of continuous improvement projects.
Knowledge, Skills, Abilities (KSAs), & Competencies:
Essential KSAs:
- Associates degree or equivalent from a two-year college or technical school and 4 years related experience and/or training or equivalent combination of education and experience.
- Familiarity with industrial manufacturing environment and predictive maintenance activities.
- Advanced understanding of machine diagnostics and complex operating systems.
- Excellent customer service and communication skills.
Desirable KSAs:
- Working toward Non-Destructive Testing (NDT) Level I certification in Ultrasound, Thermo/Infrared and Vibration.
- ISO CAT I certification in Lubrication/Oil Analysis.
- ISO CAT II certification in Vibration.
Competencies:
- Safety
- Customer Focus
- Communications
Physical Demands and Working Conditions:
While performing the duties of this job, the employee is regularly required to stand; walk; use hands/fingers to handle, or feel; reach with hands and arms; stoop, kneel, crouch; and talk or hear. The employee is also required to use a telephone with headset for verbal troubleshooting, frequent use of a standard keyboard and computer to document calls in a ticketing system, and occasional use of other office equipment. The employee must occasionally lift and/or move more than 30 pounds. The employee is occasionally required to sit for long periods and use close and color vision. Work is typically performed in a moderately noisy business office.
ATS is committed to providing equal employment opportunities in all aspects of employment to all applicants and employees without regard to age, color, race, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, disability, veteran status, genetic information, or other legally protected status. Review the privacy policy here.
ATS se compromete a brindar igualdad de oportunidades de empleo en todos los aspectos del empleo a todos los solicitantes y empleados, independientemente de su edad, color, raza, religión, sexo (incluido el embarazo, identidad de género y orientación sexual), origen nacional, discapacidad, estatus de veterano, información genética u otro estatus legalmente protegido. Revisión de la política de privacidad aquí here.
PDN-a14fac72-a351-4c7e-98fa-361d19f259c8
Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.
Company: One of Our Clients
Job Title: Assembly Operator - Entry Level - Hardware
Location: Loveland, CO 80538
Duration: 12+ Months (Extendable)
Pay Rate: $18.00-$19.60/hr. on W2
Shift: 6am – 2:30pm MST Mon-Fri
Description:
Our company is seeking a contractor to join our Hardware Manufacturing Team. In this role you will align, calibrate and execute test methods of varied complexity according to operational plans and customer demand.
You'll be responsible for following established operation procedures, maintaining appropriate training records for your role, sustaining a smooth flow of material and the execution of work orders to on-time completion.
KEY RESPONSIBILITIES:
MUST read, write and speak fluent English to understand the SOP/work instructions provided.
Proficiency with Microsoft applications. Experience with hand tools is a plus for some departments.
Able to execute assembly tasks following standard operating procedures with supervision.
Troubleshoot issues as they arise, escalating as necessary, Assure compliance with FDA Quality System Regulations (QSR).
Good Manufacturing Practices (GMP), and ISO regulatory requirements.
Learn and participate in the company's lean manufacturing principles.
Work directly and cooperatively with cross-functional team members to troubleshoot issues and ensure emphasis on quality.
Identify and recommend quality improvements including but not limited to production methods, equipment performance, product quality and efficiencies.
Maintain a safe and clean working environment by complying with procedures, rules, and regulations.
Train new team members on equipment operations and work procedures as needed.
Ability to complete appropriate paperwork, maintain accurate records of production and report status of work.
PHYSICAL DEMANDS:
While performing the duties of this job, the associate is regularly required to stand for prolonged period of time. The employee is frequently required to talk and hear; use hands to handle or feel; and reach with hands and arms above shoulder height and below the waist. The associate must be able to read and speak English. Using proper lifting techniques, the employee must be able to lift up to 30 lbs. Ability to maneuvers assembly components by hand in a repetitive manner conducive to efficiency, job specifications, safety, and quality goals. Ability to frequently stand (80%), bend, kneel, lift and sit to accomplish assembly production goals.
EDUCATION/EXPERIENCE:
High school degree (or equivalent degree). Must have 0-2 years' relevant experience. Experience in a regulated industry preferred (e.g. FDA, ISO).
Regards,
Ishendra Singh (Ishaan)
Pharma Recruiter
Net2Source Inc.
270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA
Direct: Fax: (2
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With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted hypothermic preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time. Paragonix also markets transplant services and organ screeningto the transplant community.
Position Overview: The Design Quality Engineer will play a crucial role in ensuring the quality and compliance of Paragonix's medical device products throughout the design and development lifecycle. The successful candidate will collaborate closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to drive excellence in design control processes.
Primary responsibilities/authority will include:
- Design Control Compliance: Implement and maintain design control processes in accordance with applicable regulatory standards (e.g., ISO 13485, ISO 14971, FDA QSR, MDR) to ensure the development of safe and effective medical devices.
- Risk Management: Lead and contribute to risk management activities throughout the design process, including the identification, assessment, and mitigation of potential risks. Work closely with the R&D team to integrate risk management into the design process.
- Failure Analysis: Assist in Post-Market Surveillance (PMS) initiatives, including failure investigation, record review, and data trending.
- Quality Planning: Develop and execute quality plans for new product development projects, outlining quality objectives, deliverables, and verification/validation activities.
- Design Input and Output:
- Review and approve design inputs to ensure they are clear, complete, and aligned with user needs and regulatory requirements.
- Validate that design outputs meet the specified design input requirements.
- Change Control: Manage design changes by assessing their impact on product quality, ensuring proper documentation, and obtaining necessary approvals.
- Verification and Validation:
- Develop and execute protocols for design verification and validation strategies and acceptance criteria.
- Collaborate with testing teams to ensure thorough testing of product designs.
- Collaboration: Work closely with cross-functional teams, including R&D, manufacturing, regulatory affairs, and quality assurance, to facilitate effective communication and collaboration throughout the product development process.
- Regulatory Compliance: Stay abreast of relevant regulations and standards and ensure that product designs comply with applicable requirements. Support regulatory submissions as needed.
- Continuous Improvement: Identify opportunities for process improvements within the design control system and contribute to the development and implementation of best practices.
Required Qualifications:
- Bachelor's degree in engineering or a related field; advanced degree preferred.
- Minimum of 1-3 years of experience in a quality engineering role in the medical device industry.
- In-depth knowledge of design control processes, risk management, and quality management systems (ISO 13485, ISO 14971, FDA QSR).
- Strong technical skills related to product quality including VOE translation to Design Specs, Human Factors, CTQ Cascades, Design Characterization, Verification / Validation, Test Method Validation, Process Validation, Inspection Techniques and Statistics.
- Strong understanding of regulatory requirements for medical devices (FDA, EU MDR, etc.).
- Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
- DFSS or DMAIC Black Belt Certified, ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification is a plus.
Other Requirements:
- Electrical and mechanical background strongly preferred.
- Experience creating and analyzing charts in Minitab, JMP, or equivalent software a plus.
- Knowledge of Six Sigma, Lean, SPC, ASQ and/or ISO process controls a plus.
- Computer proficiency in MS office (specifically Excel).
- Effective verbal and excellent technical writing skills.
- Excels at generating and maintaining organized and accurate records.
- Excellent oral and written communication skills in English.
- Able to travel domestically and internationally as required (
Bhagyashree Yewle, Principal Lead Recruiter - YOH SPG
ODI Developer - Hybrid Onsite in Boston MA - USC OR GC ONLY (No Visas)
- Location: Boston, MA
- Hybrid: 3 days on site
- Potential Convert: Yes, USC/GC ONLY no exceptions. WILL NOT SPONSOR
- ETL/ELT
- ODI
- PL/SQL coding
- 7 years’ experience
- Knowledge on how to be an admin side of things (not day to day but is able to do that)
- Scripting – Python & Unix Scripting
Seeking a highly skilled and experienced Sr. ODI Developer to join our Private Banking Systems team. The ideal candidate will possess expertise in a range of technologies, including ODI (Oracle Data Integrator), Oracle Data Warehouse, Linux, Python scripting, and have a deep understanding of the Banking domain is a big plus. As a Data Engineer, you will play a pivotal role in designing, developing, and maintaining data solutions.
Key Responsibilities:
- Build ODI mappings/interfaces, packages, procedures, scenarios, topology configuration, ODI Agent and load plans to integrate data from multiple enterprise systems.
- Expertise in building Pl/SQL queries, procedures, data loading process, ensuring high-performance and scalability to meet the evolving data needs of the various applications.
- Design, develop, and maintain ETL/ELT pipelines using Oracle Data Integrator (ODI).
- Collaborate effectively with cross-functional teams, including other data engineers, DBA group, analysts, and business stakeholders, to understand data requirements and deliver solutions.
- Monitor and troubleshoot RMJ jobs, ODI workflows, sessions, agents, and data pipelines on Linux environments.
- Perform root cause analysis for failures related to ODI workflows, RMJ jobs, network connectivity, API integrations, and file transfers.
- Optimize ETL workflows to improve reliability, performance, and scalability.
- Use scripting and automation tools to support data processing and operational workflows.
- Work in Linux/Unix environments, using command-line tools and shell scripts for job automation and troubleshooting.
- Maintain comprehensive documentation of data processes, configurations, and best practices.
- Participate in walk-throughs which review program specifications, source code, and all technical supporting documentation, including screens/reports. Provide feedback in accordance with team standards and guidelines.
- Participate in implementation of changes, enhancements, and newly developed programs.
- Conduct technical research and provide recommendations, develop proofs of concept or prototypes, contributing to technical design of applications.
- Helping to identify coding patterns and anti-patterns and enforce implementation of the patterns through code reviews.
- Quickly resolving issues encountered by business lines in the production environment, maintaining a helpful, "high touch" approach to working with business users, performing root cause analysis, technology evaluation, and performance tuning.
Desired Qualifications:
- Degree in Computer Science, Engineering or related technical area
- 7+ years of extensive hands-on experience in ODI, Oracle Datawarehouse, Oracle PL/SQL, Linux, Python scripting, and ODI admin module (ODI Agent setup, logs configuration, certificate installation).
- Must have experience in building Pl/SQL queries for Oracle Server (incl. stored procedures, functions…) and must understand basic principles of data modeling
- Excellent collaborative and communication skills, particularly in high-stress situations
- Experience with scripting Python and Linux scripting, CLE, networking fundamentals (API, IP/ports, SFTP/FTP connectivity)
- High proficiency in development practices: unit testing, Continuous Integration (CI/CD), refactoring, clean code
- Experience with Bitbucket/GIT source control management
- Problem solving skills, able to determine upcoming risks & issues and address them accordingly.
- Ability to interpret and troubleshoot applications using logs.
- Pro-active approach and good communication skills.
- Experience with agile methodologies (Scrum, Kanban) and tools (Jira)
- Private Banking domain experience.
- Working experience in a financial service industry
- Financial application knowledge like FIS AddVantage, CRD, CRM Pivotal.
- Experience with Apache Airflow for workflow orchestration.
- Knowledge of dbt (Data Build Tool) for modern data transformations.
- Exposure to cloud data platforms or hybrid data architectures.
Key Competencies:
- Strong analytical and problem-solving skills
- Ability to work with large-scale enterprise data environments
- Excellent collaboration and communication skills
- Ability to manage multiple priorities in a fast-paced environment
- Commitment to continuous learning and technology innovation
Estimated Min Rate: $55.00
Estimated Max Rate: $72.00
What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:
- Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
- Health Savings Account (HSA) (for employees working 20+ hours per week)
- Life & Disability Insurance (for employees working 20+ hours per week)
- MetLife Voluntary Benefits
- Employee Assistance Program (EAP)
- 401K Retirement Savings Plan
- Direct Deposit & weekly epayroll
- Referral Bonus Programs
- Certification and training opportunities
Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.
Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Visit to contact us if you are an individual with a disability and require accommodation in the application process.
For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: working/work at home options are available for this role.