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Design and Mechanical Engineer – Medical Devices

Join a global leader medical device company. Design and manufacture technology used in spine and orthopedic surgeries

You will work on the design and development of surgical implants and instruments, collaborating with engineers, surgeons, and cross-functional teams to bring innovative products to market.

Full‑time | W2 | M-F 8am- 5pm | On site Audubon PA (outside of Philadelphia)

Qualifications

• 4+ years of mechanical and medical device design engineering experience.
• II and III medical device experience
• Experience with CREO or SolidWorks for mechanical design and documentation.
• Experience working within regulated environments (ISO 13485 / FDA).
• Ability to work in both engineering and clinical environments, including operating rooms and labs
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Bioengineering, or related field.

Benefits:

Visa sponsorship supported within US

W2 contract

Audubon, PA (outside Philadelphia)

Bonus for relocation within US and annual bonuses

Work directly with surgeons

Full product development lifecycle exposure

Key Responsibilities

Product Development

• Lead the design and development of surgical instruments and implants using CAD software (CREO).
• Develop and maintain project plans and FDA-compliant Design History Files (DHF).
• Perform design verification and validation to ensure designs meet technical specifications.
• Manage assigned projects to ensure timely completion while maintaining compliance with regulatory requirements.
• Collaborate with internal prototype teams and external vendors for rapid prototyping and testing.
• Support preparation of regulatory submissions to the FDA.

Customer Engagement

• Work directly with surgeons and clinical users to gather product feedback and translate clinical needs into design requirements.
• Participate in product launches, sales training, and customer visits.
• Support surgical cases in the operating room to observe device performance and identify opportunities for improvement.

Cross-Functional Collaboration

• Partner with marketing and product management to develop market strategies and forecasts.
• Collaborate with operations and manufacturing to support production and commercialization.
• Conduct competitive and industry research to ensure innovative product development.

Product Lifecycle & Sustaining

• Support the lifecycle management of commercialized products.
• Drive design improvements, cost reduction initiatives, and engineering changes.
• Work closely with Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure product performance and compliance.

The IN group is here to support you specifically with the recruitment and hiring process for job opportunities. Our role is focused on guiding you through these steps. If you have any questions related to your application or next steps in the hiring process,

Apply, and please feel free to reach out.

Full-time Maintenance Technician needed in Hutchinson, MN. Company is a global high-tech manufacturing company for the medical device industry; this company has grown 20% over the last 6 years (43% in 2025). Pay rate is $38 to $44 per hour plus the 15% 2nd shift differential with full benefits. Schedule Monday-Thursday 4:00 pm- 2:30 a.m. Position is open due to retirement.

Overview:

This position employs an individual for the purpose of providing technical support for internal equipment. This position concentrates primarily on the timely completion of assigned tasks to maintain established preventative maintenance schedules and to effectively repair unplanned equipment failures in a timely manner. Additional areas of focus include but are not limited to: PC support, process control, machine assembly and fabrication, programming and wiring, procedural recommendations, records keeping, equipment refurbishments, and advanced troubleshooting. The hands-on nature of this position must be emphasized.

Responsibilities:

Complete equipment refurbishment, assembly, fabrication as required.

Review existing service procedures for accuracy and make recommendations to maintain compliance with ISO maintenance requirements.

Perform troubleshooting and repair of equipment and ancillary support systems utilizing outside service help as needed to minimize machine down time.

Perform various equipment and systems related planned and unplanned maintenance activities including timely completion and filing of service records.

Make recommendations regarding updates to Preventive Maintenance procedures and frequencies.

Establish and maintain on-hand spare parts inventory for equipment.

Coach and provide feedback to Manufacturing personnel on equipment care, operation and process.

Provide Process Engineering support on equipment by monitoring indicators, troubleshooting and providing feedback including relevant data, observations, actions taken and results achieved.

Qualifications:

2 year Degree/Diploma in Robotics, Instrumentation, Automation or relevant Electro-Mechanical field

Demonstrated ability to apply the theories and principles of the following disciplines

Physics

Mathematics

Hydraulics/Pneumatics

AC/DC wiring – electrical theory

Electronics

Geometric Dimensioning and Tolerancing

Statistical Process Control

Job Description

Job Summary:

Manages a team of chemists/scientists/technicians and executes pressure sensitive adhesive (PSA) tape prototype development, scale-up, and product launch in various applications. The group leader will focus on platform technology development, new product development for customer-driven projects, as well as continuous improvement and cost reduction of existing products and processes. Emphasis on acrylic polymer synthesis, silicone and rubber adhesive formulations, PSA rheology, knowledge of tape assemblies, backing material selection, and release liner familiarity. Works with customers and AR teams to collect design input and develop new product design strategies. Technical and laboratory lead in developing new adhesive solutions, robust products, and basic production processes that can be successfully commercialized.

Essential Functions:

• Establishes and directs research programs for new product development and product/process improvement of current products. Responsible for complex basic research and/or product development projects.
• Leads lab personnel and facilitates development of product constructions and processes; designs & conducts chemical experiments on both lab- and production-scale; designs and specifies production scale processes and contributes to product validation.
• Conducts and directs required laboratory work to develop new PSA and tape assemblies including polymerization, formulation, coating and testing. Develops new products that lead to sustainable commercial revenue.
• Completes any necessary regulatory forms. Ensures team follows similar protocols and procedures.
• Implements and executes product development to align with Stage Gate timelines and sets prioritization with the Director of Innovation and Product Management team. Meets technical commitments in order to complete project progression dates and milestones on time.
• Drives patent strategy (reading, planning, and execution) within the team to align with goals established by the Director of Innovation.
• Consults with Director of Innovation, Product Management, Operations, Quality and Sales personnel on group priorities and strategy. Active role in setting overall Innovation direction & strategy. Participates in business planning process with one or more business as appropriate. Establishes program priorities, objectives and responsibilities for group. Ensures effective communication of Innovation program progress for own work and for overall group.
• Functions as a technical lead on product development teams. Leads cross-functional product development teams to ensure effective prototype development, to drive prototypes to commercial products, and to translate findings into impactful business revenue.
• Participates and occasionally leads establishment and implementation of R&D policies and procedures. May be responsible for specified lab areas.
• Interfaces with customers on new product applications and networks externally to assure highest level of competence is maintained.
• Develops skills within the team and evaluates performance of department personnel. Mentors and and coaches associates to effectively work in the department in addition to promoting a collaborative work environment (within the department and cross-functionally). Executes performance reviews annually.
• Makes identifiable and substantial contributions to continuous improvement. Performs all duties consistent with established AR guidelines consistent with ISO-9001 and those elements of GMP deemed necessary to support our business (as outlined in the Quality Manual). Actively complies with and endorses Department and Company objectives.
• Responsible for the proper disposal of hazardous waste into the proper labeled containers and drums.

Additional Responsibilities:

• Perform other related duties as assigned by management.

Job Specifications:

• BS degree (or higher) in chemistry, chemical engineering, polymer science or materials science and/or significant industrial experience. Ph.D. degree preferred but not required.
• Greater than 3 years adhesive formulation, mixing process and coating process experience. Demonstrates detailed knowledge of required chemical and physical test methods for PSA characterization. Requires an aptitude to use sensitive test equipment.
• Basic understanding and familiarity with adhesive chemistries and coating technologies. Familiarity and understanding of various adhesive chemistries (acrylic, silicone, rubber).
• Understanding of adhesive tape constructions (backing materials, release liner selection, adhesive chemistries, etc.)
• Knowledge of PSA rheology, dynamic mechanical analysis, and other physical polymer characterization methods
• Supervisory experience preferred with experience managing a team of scientists in product development, technology platform expansion, and patent filing.
• Demonstrated technology and/or product development capability.
• Expertise required in Stage Gate processes and how to move projects through the pipeline with discipline, efficiency, and accountability
• Excellent program prioritization and coordination skills, ability to manage multiple priorities
• Ability and willingness to work effectively in a diverse, disciplined team environment with limited supervision. Ability to work independently and drive project execution with limited guidance.
• Excellent program prioritization and coordination skills, ability to manage multiple priorities.Agility to adapt and shift to changing priorities, proactively anticipating obstacles, and flexibility to seek out alternative solutions when faced with meeting customer design inputs and timelines
• Must communicate fluently in English
• Ability to maintain confidentiality of AR information
• Excellent oral & written communication skills
• Excellent interpersonal skills
• Knowledge of computers & related word processing, spreadsheet & e-mail software – Microsoft preferred
• Ability to employ statistical analysis techniques. Familiarity with design of experiments software and set-up, ability to employ statistical analysis techniques
• Ability to develop and present effective technical presentations to internal and external customers.

About the Role:

As a Multi-Site EHS Manager, you will work on a variety of risk reduction, continuous improvement, regulatory, and culture-based projects. Activities include, but are not limited to, daily interaction with all levels of the organization at the facility, analyzing and prioritizing risk and injury trends, facilitating company EHS initiatives, and mentoring/coaching the local team towards an engaging EHS culture. This position is responsible for driving world class EHS performance. You will oversee the EHS programs and ensure compliance with company and regulatory requirements. This position will help create and communicate an attainable vision for the operations and strategically lead them toward those goals.

Your Responsibilities:

• Develops, implements, and maintains the Company's EH&S management system to ensure compliance with applicable Federal, State, and Local regulations and standards including those for general industry, industrial hygiene, fire safety, confined space, powered industrial truck, hazardous waste, ISO 14001, and clean air requirements
• Responsible for full integration of safety and environmental management into the facility's operations. Works with facility management to ensure the facility safety and environmental goals are met
• Remains knowledgeable and well-versed on all pertinent information and developments in Federal, State, Local laws, and Company regulations/requirements
• Assists in the verification that hazardous chemicals are handled, stored, and disposed of in accordance with regulations
• Educates, trains, and provides support to operations in the development and execution of consistent safety and environmental management programs
• Conducts environmental audits to ensure adherence to environmental standards
• Files appropriate compliance reports with regulatory agencies
• Ensures all training is completed in compliance with Federal, State, Local laws, and Company regulations/requirements
• Manages Company safety investigation process, conducts root cause analysis and identifies sustainable corrective actions to eliminate repeat incidents
• Ensures effective and timely communications across all levels of the organization
• Must be a change agent and can quickly adapt to and influence change
• Can manage across multiple manufacturing facilities that may be adjacent to each or regionally close
• Other duties as assigned

Let's Talk About Your Qualifications:

• Bachelor's Degree in EHS related field
• 3 years of experience in a manufacturing facility preferred
• Working knowledge of state Worker's Compensation Regulations
• Proficient in Microsoft Office Products
• Working knowledge of OSHA, DOT, and EPA standards
• Strong verbal and written communication skills
• Analytical Thinking Skills -- job requires analyzing information, using logic to address work-related issues and problems
• Excellent organizational skills with a strong ability to multi-task in a fast-paced environment
• Strong interpersonal skills with the ability to work with all levels of the organization as well as external parties.

Leadership Attributes:

At Wabash, we pride ourselves on being empowering, and there are some things we feel very strongly about:

• Embrace Diversity and Inclusion -- Solicit and respect the input of others, celebrate differences, and strive for transparency and inclusiveness
• Seek to Listen -- Actively listen to reach the best solution and make the strongest decisions
• Always Learn -- Strive to improve; do not quit or settle for the status quo
• Be Authentic -- Demonstrate honesty, incredible energy, and grit in everything you do
• Win Together -- Collaborate, seek alignment, and excel at cross-group communication to success as one team and One Wabash

Join us in turning ideas into world-changing realities. Curate and build your high-impact professional career at Wabash!

Affirmative Action/EEO Statement:

Wabash is committed to providing equal employment opportunity for its associates and applicants without regard to race, color, religion, sex, age, national origin, veteran status, disability, or other protected class or activity under federal, state, or local law. All employment decisions must be based on neutral, legitimate criteria. All employment policies and rules shall be applied equally to similarly situated associates.

Grays Specialty Equipment segment offers a comprehensive range of expert services to design, manufacture, integrate, install, and maintain some of the most advanced systems on the market. The Specialty Equipment segment includes Anderson Dahlen, located in Ramsey, MN, and Waconia, MN. Anderson Dahlen delivers end-to-end equipment design-build and contract manufacturing, with precision fabrication cutting, forming, machining, welding, finishing, and complex assemblies backed by engineering, integration, and complete process solutions including skids and sanitary platforms tailored to customer applications. Anderson Dahlen is ISO 9001:2015 certified, as well as ASME, AWS, and PED compliant.

The wage range for this role takes into account a wide range of factors that are considered in making compensation decisions, including but not limited to skill sets, experience and training, certifications, as well as other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. It is not typical for an individual to be hired at or near the top of the range for their role, and compensation decisions are dependent on the facts and circumstances of each case. A reasonable estimate of the current range is $22-$35/hour.

Our comprehensive health plan options, including medical, dental, and vision insurance, provide our team members with the tools they need for treatment, preventative care, exams, and prescriptions. ADIs life, disability, and supplemental insurance options provide peace of mind and support to rely on in challenging times. Our team members overseas are offered private health insurance, life insurance, and an employee assistance program (EAP).

PRIMARY OBJECTIVE/QUALIFICATIONS OF THE POSITION:

• Performs a full range of rough grinding, polishing, and metal finishing operations on components, manufactured parts, and assemblies in accordance with prescribed specifications, quality standards, and safety requirements.
• Follow all safe work practices and OSHA requirements.
• Grind, file, sand, polish, and blend metal surfaces using hand tools, power tools, and finishing techniques.
• Examine and feel metal surfaces to detect defects such as dents, scratches, or material imperfections.
• Set up and operate straight-line sanders, buffers, Timesavers, and hand-held grinders and polishers.
• Select proper abrasives and finishing methods to achieve specified finishes efficiently and consistently.
• Read, understand, and apply blueprints, customer requirements, and written or verbal work instructions.
• Complete projects within established timeframes while meeting or exceeding quality standards.
• Monitor and maintain quality of finished goods throughout the process.
• Use profilometers and other measuring tools to verify surface finish requirements.
• Stage work and operate equipment independently as skill level allows.
• Develop, improve, and standardize finishing processes and techniques while maintaining high quality standards.
• Contribute to continuous improvement, cost-saving initiatives, and quality enhancements.
• Train, mentor, and support other finishers as experience level allows.
• Work effectively in a team environment and maintain positive working relationships.
• Understand and follow all company policies and procedures.
• Perform other duties as assigned.

PHYSICAL REQUIREMENTS:

The company fosters a manufacturing-type environment. Moderately heavy work requires the occasional lifting of objects weighing 50 pounds or less. In the performance of essential duties, the incumbent may be required to operate a variety of industrial machining tools.

• Lift/Carry-
• 0-10 lbs. continuously.
• 11-50 lbs. frequently
• 51-100 lbs. never
• Push/Pull-
• 0-25 lbs. continuously
• 26-100 lbs. frequently
• Bend- 34-66% during a 10-hour shift.
• Twist/Turn- 34-66% during a 10-hour shift.
• Kneel/Squat- 0-33% during a 10-hour shift.
• Sit- 0-33% during a 10-hour shift.
• Stand/Walk- 0-33% during a 10-hour shift.
• Overhead Reaching- 0-33% during a 10-hour shift.
• Ladder/Stair Climb- 0-33% during a 10-hour shift.

EEO DISCLAIMER:

Gray is proud to be an Equal Opportunity Employer and welcomes everyone to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Compensation details: 22-35 Hourly Wage

PIc6c41658b437-26289-39837399

Principal Duties/Responsibilities:

* Performs a variety of technical services under direct supervision and instruction

* Coordinates and completes activities of assigned projects within a given timeframe

* Forms and develops relationships with team members and internal/external customers

* Assists implementation of new systems, processes, services, and product families

* Actively participates in regular team meetings to review issues, concerns, and activities

* Participates in developmental activities including team presentation preparation and delivery, meeting agendas and minutes, interaction with internal and external guest speakers, soft skill training sessions, and mentor coaching relationship

* Interacts with customers to include service follow-up and status reports

* Adheres to all ISO processes, procedures, and policies

* May include administrative duties including preparation of reports/charts, filing, and documents

Knowledge, Skills, Abilities, & Behaviors Required:

* Must be a current full time student of either a high school, college or technical institution, depending on the tasks assigned in the job design; or up to one month related experience or training; or equivalent combination of education and experience

* Participates in the Service/Quality Initiative and Continuous Improvement Processes

* Completes required quality core classes and uses skills and techniques presented

* Adheres to ATS and/or customer safety procedures

* Must be a team player, organized, self-motivated, and able to prioritize

* Ability to read, interpret, and create documents and correspondences

* Proficient computer and software skills

* Knowledge of basic algebra and geometry concepts

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; climb, ascend/descend or balance to heights that may require a ladder or lift; stoop, kneel, crouch, or crawl in confined spaces; and talk or hear. The employee is occasionally required to sit. The employee must occasionally lift and/or move more than 50 pounds. The employee is regularly required to use close vision and color vision. The employee is occasionally exposed to outside weather conditions and risk of electrical shock. Work is typically performed in a factory environment and is usually very loud. In the factory environment, the employee may be exposed to hazardous materials and/or greasy or slippery factory floors.

Position Summary

Leo Cancer Care is seeking an experienced In-House Counsel / General Counsel to serve as the company’s lead legal advisor and a strategic partner to the CEO, executive team, and Board of Directors. This is a hands-on leadership role in a fast-moving, FDA-regulated medical device environment.

The General Counsel will oversee all legal affairs across the U.S. and European markets, ensuring strong corporate governance, regulatory compliance, risk management, and legal infrastructure to support a high-growth organization. This role requires deep experience in commercial contracting, corporate and securities matters, intellectual property strategy coordination, and FDA-regulated business operations.

The successful candidate will also play a critical role in helping position the company for future strategic transactions and potential public market activity by building the legal, governance, disclosure, and compliance infrastructure necessary for IPO readiness and public company operations. This includes partnering with executive leadership, finance, and external advisors on securities matters, disclosure controls, Board governance, and legal support for major financing and capital markets initiatives.

This position is ideal for a seasoned attorney who can operate independently with minimal oversight, proactively identify risk, provide practical business-aligned solutions, and help prepare the company for long-term growth, strategic transactions, and potential public offering readiness.

Key Responsibilities

Strategic Legal Leadership & Governance

• Serve as a trusted legal advisor to the CEO and executive leadership team
• Provide legal guidance to the Board of Directors on governance, fiduciary duties, and corporate matters
• Establish and maintain corporate governance frameworks, policies, and internal controls appropriate for a scaling organization
• Support fundraising activities, investor relations, disclosures, and capital markets strategy
• Help prepare the organization for IPO readiness and public company governance, including disclosure processes, insider trading policies, governance frameworks, and Board committee structures
• Advise leadership on securities law, disclosure obligations, and governance best practices applicable to a company preparing for potential public market participation
• Partner with Finance and external advisors to support public-company readiness initiatives, including legal support related to S-1 preparation, SEC reporting readiness, disclosure controls, and SOX-related compliance planning

Commercial Contracts & Procurement

• Draft, review, and negotiate a broad range of commercial agreements, including:
• Vendor and supplier agreements
• Purchasing and manufacturing contracts
• Consulting and contractor agreements
• NDAs, MSAs, SOWs
• Distribution and service agreements
• Partner closely with Operations, Engineering, Supply Chain, and Commercial teams
• Build scalable contracting processes, templates, playbooks, and approval workflows
• Balance legal risk with business priorities in a pragmatic, solutions-oriented manner

FDA-Regulated Environment & Compliance Support

• Provide legal support for business activities within an FDA-regulated medical device environment
• Partner with Regulatory and Quality teams to ensure alignment between commercial execution and compliance requirements
• Advise on:
• Quality system-related matters (as applicable)
• Labeling and promotional review
• Customer contracting and regulatory considerations
• Support ISO 13485 Quality Management Systems alignment
• Oversee compliance with FDA, EU MDR, and applicable international healthcare regulations

Corporate, Securities & Equity Administration

• Support corporate governance matters, including Board and investor materials, resolutions, committee matters, and governance documentation
• Provide legal oversight for:
• Stock option plan administration and equity documentation
• Cap table-related legal considerations
• Private company securities compliance
• Partner with Finance and external counsel on fundraising rounds, securities compliance, and disclosure obligations
• Support legal workstreams related to IPO preparation, including external counsel and auditor coordination, due diligence support, governance readiness, and development of processes aligned with future SEC reporting requirements
• Help establish legal infrastructure for public company transition readiness, including documentation standards, disclosure support processes, and policy development

Intellectual Property (IP) Strategy & Legal Risk Management

• Serve as internal lead for IP triage and strategy coordination
• Identify patentable inventions and coordinate filings with outside patent counsel
• Manage invention disclosures and support IP portfolio development
• Support trademark strategy and proprietary technology protection
• Partner with Engineering and Product teams to ensure confidentiality safeguards and trade secret protection

Corporate Transactions & Strategic Initiatives

• Support strategic transactions and corporate initiatives, including:
• Review and negotiation of Stock Purchase Agreements (SPAs)
• Strategic partnerships and licensing agreements
• Distribution and commercial expansion arrangements
• Coordinate due diligence workstreams with external counsel
• Provide legal support for cross-border transactions and EU market activities
• Support potential M&A, strategic investments, financing transactions, and capital markets initiatives

General Legal & Business Support

• Provide practical legal guidance across HR, privacy, employment, and general business risk
• Identify and mitigate legal and regulatory risks while enabling innovation
• Build legal infrastructure appropriate for a scaling, high-growth organization
• Manage external counsel efficiently, including scoping, budgeting, and prioritization
• Optimize legal spend while ensuring high-quality support

Required Qualifications

• Juris Doctor (JD) from an accredited law school
• Active bar membership in at least one U.S. jurisdiction (in good standing)
• 10–15+ years of relevant legal experience (combination of in-house and/or top-tier law firm experience)
• Significant experience negotiating complex commercial agreements
• Experience supporting corporate governance and securities matters in a U.S. company environment
• Demonstrated ability to operate independently and serve as a trusted advisor to executive leadership and boards
• Strong commercial judgment and business acumen

Preferred Qualifications

• Experience in medical devices, biotech, life sciences, or other FDA-regulated environments
• Experience supporting high-growth and scaling organizations
• Direct experience supporting IPO readiness, SEC registration processes, public-company governance, or ongoing public-company compliance
• Experience preparing companies for major financing rounds, strategic transactions, or capital markets activity
• Experience with:
• Stock option plan administration and equity documentation
• Private company securities compliance
• S-1 and SEC disclosure coordination
• Disclosure controls and SOX-readiness planning
• IP triage and coordination with patent counsel
• SPAs and strategic corporate transactions
• Familiarity with EU regulatory frameworks (EU MDR)

Core Competencies

• Strong commercial judgment and negotiation skills
• Strategic thinker with executive presence
• High integrity and discretion
• Clear, confident communicator across technical and executive audiences
• Solutions-oriented and pragmatic
• Comfortable with ambiguity and building processes from the ground up
• Ability to prioritize effectively in a fast-paced, regulated environment

Why Join Us

This is a rare opportunity to build and lead the legal foundation of a transformative cancer care technology company at a pivotal stage of growth. The General Counsel will play a critical role in enabling innovation, safeguarding the company’s mission, supporting strategic expansion across the U.S. and EU markets, and helping position Leo Cancer Care for long-term success, including readiness for future strategic transactions and potential public market participation.

The Senior Manufacturing Engineer is accountable for providing technical support for the assigned processes and equipment to operations. Ensure that processes and equipment meets expectations for performance and operational requirements. Validates that processes meet operational requirements and goals.

Responsibilities

• Be actively engaged with the manufacturing process and operations teams. Participate in the Daily Tier accountability meetings.
• Troubleshoot production process/technical problems in real time to deploy countermeasures. Work closely with the shift supervisor/s, other ME, IE, Lean Expert, Design, R&D, facilities/maintenance, and quality team members to gain cross functional feedback.
• Provide day-to-day technical floor support as a SME (Subject Matter Expert). Investigate and resolve issues which arise during the manufacturing while maintaining or exceeding safety, quality, productivity, and cost goals.
• Utilize various RCA (Root Cause Analysis) tools to correct the problems and prevent it from re-occurring. Analyze data to improve process capability, reduce process variation, and optimize process performance.
• Develop processes to improve the throughput using lean manufacturing methodologies. Lead continuous improvement projects in assigned process areas to reduce waste/scrap and cycle times.
• Design and construct tooling/fixtures for processes or modify existing production equipment as needed. Identify and develop relationship with external suppliers (tool and die shops) to upgrade tooling and fixtures.
• Select and integrate off-the-shelf component and equipment. Able to confirm system's and components' capabilities by designing test methods and procedures. Understanding of the hardware and physical system being controlled is necessary.
• Lead the project implementation by reviewing installation plans, coordinating start-ups, documenting changes, updating procedures, and training operators. Maintain project documentation and assist in creating Operation Manuals
• Assist in product design, material selections, and tooling reviews. Capability to select and integrate off-the-shelf component and equipment. Ownership of the Process Failure Modes and Effects Analysis (PFMEA) for assigned processes.
• Develop standardized Work Instructions and/or procedures for the assigned areas. Lead train the trainer sessions for assigned areas. Ensures production team knows about the proper operation of equipment through training, verification and process audits.
• Provide direction and coordinate efforts and responsibilities for interns and co-ops to best suit the needs of the business.
• Must be able to multitask and handle shifting priorities on short notices.
• Quality Support: Provides support during the customer or regulatory audits, Support ISO Re-implementation related activities, participate in the Change Management initiatives as needed.
• Support the Senior Manufacturing Engineering Manager in the Strategic Planning of the Short Term (1-3 years) and Long Term (3-5 years) Capital Spending Goals for the site.
• Assist the maintenance team in developing the Critical Spares of various process equipment in their area.
• Provide prompt support to the on-site team during troubleshooting/problem solving in presence or remotely to avoid the unplanned downtime and improve the OEE.
• Support the Senior Manufacturing Engineering Manager in the interview process of the new recruits and on-boarding the new manufacturing team members in the department.
• Other duties, responsibilities and activities as assigned at any time with or without notice

Knowledge, Skills, and Abilities

• Strong communication and documentation skills.
• Strong knowledge of automation skills (PLCs, SCADA, and Robotics)
• Statistical capability analysis skills.
• Proactive problem solver.
• Direct experience working in a manufacturing environment is required.
• Time management, organizational and multi-tasking skills necessary to work in a fast-paced environment, handling various tasks and changing priorities.
• High attention to detail and accuracy to achieve daily assignments and goals.
• Ability to analyze, review, and make recommendations.
• Strong verbal and written communication skills.
• Ability to make engineering judgment decisions.
• Elicits cooperation and influences others to drive business strategies, goals, and objectives.
• Demonstrated hands on problem solving utilizing good engineering principles.
• Knowledge of Six Sigma and Lean Manufacturing techniques.
• Experience with CAD software (AutoCAD, SOLIDWORKS, Creo, etc.)

Education and Experience

• Bachelor's degree in electrical engineering or other engineering disciplines with appropriate skills/experience or equivalent experience.
• Minimum of 8 years' experience.

Travel

• Local Travel
• Overnight/North America: Less than 10%

Working Conditions

• Office Environment - Must be able to remain in a stationary position 50% of the time and occasionally move about inside the office to access file cabinets, office machinery, etc. Required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading. May be required to exert up to 25 pounds of force occasionally to lift, carry, push, pull or otherwise move objects, including the human body.
• Factory - The worker may be subject to hazards. Includes a variety of physical conditions, such as proximity to moving mechanical parts, vibration, moving vehicles, electrical current, exposure to temperature changes or exposure to chemicals. While performing the duties of this job, the employee may be exposed to fumes, airborne particles, odors, dust, mists, and gases. The noise level in the work environment can be loud. Required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes. Machinery operation requires the use of safety equipment to include but not limited to eye safety glasses, hearing protectors, work boots, and lab coats. May be required to exert up to 50 pounds of force occasionally to lift, carry, push, pull or otherwise move objects, including the human body.

Department

Research & Development (R&D)

Summary

nRichDX is seeking an R&D team member whose primary responsibility will be quality control and functional testing of nucleic-acid extraction kits (cfDNA/cfRNA/cfTNA/CTC-related), supporting product releases and manufacturing scale. This role will also contribute to routine R&D workflows, including method verification, troubleshooting, documentation, and data generation for continuous improvement and external deliverables.

Key Responsibilities

Kit QC & Functional Testing (Primary)

• Own and execute functional testing plans for commercial kit lots (incoming components, in-process, and final kit performance testing).
• Run routine QC assays, including (as applicable):
• qPCR/RT-qPCR (recovery, inhibition checks, linearity)
• TapeStation/Bioanalyzer (size profiles, integrity, yield QC)
• Fluorometric quantification (Qubit/PicoGreen/RiboGreen)
• Extraction performance checks (yield, reproducibility, carryover, contamination controls)
• Prepare and process biological samples (plasma/urine/whole blood and contrived controls) according to SOPs.
• Track lot performance, generate QC summaries/CoA-support data, and flag out-of-spec trends.
• Investigate deviations and failures, perform root-cause analysis, and recommend corrective actions with R&D, Manufacturing, and Quality.

Cross-Functional Support

• Partner with Manufacturing to ensure smooth tech transfer and readiness for scale (materials, build records, test readiness).
• Coordinate with Quality on documentation, change control support, and release criteria.
• Support troubleshooting of customer-reported issues by recreating conditions and documenting findings.

Routine R&D Work (Secondary)

• Assist with protocol optimization, method verification, and robustness studies.
• Support automation workflows as needed (e.g., Hamilton or internal platforms), including run setup, execution, and data review.
• Maintain lab organization, instrument upkeep, reagent preparation, and inventory management.
• Maintain high-quality documentation: lab notebooks, raw data files, SOP updates, and summary reports.

Qualifications

Required

• B.S. in Molecular Biology, Biochemistry, Chemistry, Biomedical Engineering, or related field (M.S. preferred).
• 2+ years hands-on experience in a molecular biology lab (industry preferred).
• Demonstrated experience with DNA/RNA extraction and qPCR/RT-qPCR.
• Strong attention to detail and comfort working in a structured, repeatable testing environment.
• Ability to produce clear documentation and communicate results to cross-functional teams.

Preferred

• Experience with cfDNA/cfRNA/cfTNA workflows, low-input samples, or liquid biopsy.
• Experience with TapeStation/Bioanalyzer, NGS library QC, or inhibition/contamination control strategies.
• Familiarity with GxP/ISO concepts, change control, deviations, and data integrity principles.
• Experience supporting automation platforms (Hamilton, etc.).
• Comfortable analyzing data in Excel; bonus for basic stats/graphing or scripting.

Skills & Attributes

• Highly organized, reliable, and execution-focused.
• Strong troubleshooting mindset and ability to identify patterns/trends across lots.
• Collaborative and comfortable working with R&D, Manufacturing, and Quality.
• Able to manage multiple tests/priorities while maintaining accuracy.

Working Conditions

• Lab-based role handling human-derived specimens (with appropriate training and PPE).
• May require occasional schedule flexibility to support builds, releases, or time-sensitive studies.

Success Metrics (First 3–6 Months)

• Independently executes the functional testing plan for kit lots with minimal supervision.
• Produces consistent, audit-ready QC documentation and summaries.
• Helps reduce retests/failures via early detection of issues and clear root-cause investigations.
• Contributes meaningfully to routine R&D studies and continuous improvement efforts.

• Develop, implement, and maintain the Quality Management System (QMS).
• Plan, conduct, and coordinate internal and supplier audits to ensure compliance with regulatory and accreditation standards (e.g., CLIA, CAP).
• Manage document control, change control, CAPA, nonconformance management, complaint handling, and MDR/Vigilance activities.
• Coordinate proficiency testing programs and analyze results to identify trends and improvement opportunities.
• Ensure all required regulatory licenses and accreditations remain current.
• Maintain quality documentation, SOPs, and laboratory testing procedures.
• Prepare, analyze, and present quality metrics and reports for management review.
• Train and onboard new personnel; review training documentation and monitor ongoing competency of testing staff.
• Maintain working knowledge of laboratory protocols, specimen processing, equipment operation and maintenance, and data analysis.
• Review and approve product labeling, packaging, promotional materials, and technical documentation for regulatory compliance.
• Monitor changes in global regulations, standards, and guidance; assess impact and recommend updates to internal processes.
• Partner with cross-functional teams (R&D, manufacturing, engineering, clinical, marketing) to embed quality and regulatory requirements early in product development.
• Lead or support management reviews, regulatory and quality training programs, and continuous improvement initiatives.
• Prepare, submit, and maintain regulatory filings, documentation, and reports.
• Coordinate with regulatory and accreditation bodies to support product approvals, certifications, and inspections.
• Ensure compliance with internal health and safety policies; report and address violations as required.
• Participate as an external auditor on College of American Pathologists (CAP) inspection teams, as required by the CAP accreditation program.
  
  

• Bachelor's degree (required) in life sciences, biology, chemistry, engineering, pharmacy, or related field; Master's a plus
• 3+ years of laboratory experience, including experience with audits, compliance systems, and regulatory submissions.
• Strong knowledge of key regulations and standards: FDA QSR (21 CFR Part 820/211), ISO 13485/9001, EU MDR/IVDR, GMP, ICH guidelines, etc.
• Working knowledge of relevant regulatory frameworks
• Professional certification is a plus (i.e, Regulatory Affairs Certification – RAC, ASQ Certified Quality Auditor – CQA).
• CLS Generalist or CGMBS license preferred
• Proven knowledge of quality assurance terminology, software, methods, and tools.
• Previous experience with Laboratory Information Management Systems is preferred.
• Proficient in QMS software (i.e. MediaLab, TrackWise, MasterControl or similar)
• Strong analytical, problem-solving, and decision-making skills.
• Experience in compliance and/or regulatory and knowledge of laboratory standards and regulations
• Experience with Microsoft Office Suite; Word, Outlook, Excel
• Excellent written and verbal communication skills for agency interactions, technical writing, and cross-functional collaboration.
• Able to effectively present information and respond to questions from various stakeholders