Engineering Jobs in Upper Montclair New Jersey
82 positions found — Page 5
Duration-: 10+ Months
Location: Remote
Overview
An experienced Solution Architect to lead the enterprise rollout of Microsoft Purview across a complex global, multi cloud environment. The consultant will define architecture, implement domain?based governance, and drive adoption of Purview capabilities including cataloging, lineage, classification, access governance, and compliance controls.
Key Responsibilities
- Architecture & Implementation
- Define target?state architecture for Microsoft Purview across Azure, AWS, M365, on prem, and third party platforms.
- Develop and drive the implementation roadmap across U.S. Businesses, PGIM, Corporate Technology, and international units.
- Establish Purview reference architecture, integration patterns, and guardrails.
- Domain Based Governance
- Design collections, hierarchies, and RBAC aligned to domain structures and legal entity boundaries.
- Enable domain owned stewardship while enforcing enterprise taxonomies and governance standards.
- Platform Configuration
- Configure Data Map, Catalog, Scans, Classifications, Sensitivity Labels, and Lineage.
- Optimize scan strategy (frequency, cost, performance) and extend classifiers and metadata models.
- Security & Compliance
- Integrate Purview with M365 Information Protection, Entra ID, and security baselines.
- Support PII/PCI/PHI detection, access governance, and regulatory compliance (SOX, GLBA, NYDFS, GDPR).
- Engineering & Integration
- Integrate with Synapse, Fabric, Databricks (including Unity Catalog), Snowflake, SQL Server, AWS sources, and SAP/Oracle.
- Implement IaC (Bicep/Terraform), CI/CD for Purview artifacts, and automation via APIs.
- Adoption & Stakeholder Management
- Deliver training, onboarding playbooks, and steward enablement.
- Lead workshops for new data domains and products.
- Provide executive level reporting on progress, risks, and KPIs.
Required Qualifications
- 10+ years in data architecture/governance; 2+ years hands on Purview experience at enterprise scale.
- Strong expertise in metadata management, lineage, classification, scan optimization, glossary management and domain based operating models.
- Solid Azure ecosystem knowledge (Storage, Key Vault, Synapse, Fabric, Databricks), M365 Information Protection, and Entra ID.
- Experience with IaC (Bicep/Terraform), APIs/Atlas, and scripting (PowerShell/Python).
- Financial services or regulated industry exposure.
- Excellent communication, stakeholder leadership, and cross domain facilitation skills.
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.
Job Overview
The primary responsibility for the Sustaining Engineer II position focuses on Design Verification and Validation activities, supporting testing for regulatory submissions, CAPA execution, writing and executing Test Method Validations, and working with component suppliers. This position will report to the Sustaining Engineering Manager.
Job Responsibilities and Essential Duties
- Write and execute protocols, such as Design Validations or Verifications. Compile, analyze and report protocol test data.
- Write and execute Test Method Validations. Compile, analyze and report testing data.
- Update Design Specifications, Risk Management Plans and Reports, FMEAs, or other risk management documents.
- Investigate and plan CAPA activities
- Communicate and Coordinate activities with other Getinge sites and outside component suppliers.
- Implement documentation changes as needed. (Engineering specifications, change notices, manufacturing procedures, and other documentation).
- Comply with Quality System Procedures, Good Lab Practices, and Exposure Control Plan.
- Develop processes, methods, tooling, and production controls; supervises their assembly and proofing.
- Prepares presentations reflecting the status and results of projects.
- Lead small projects that support product enhancement and cost savings opportunities.
- This is not an inclusive list of job responsibilities.
Minimum Requirements
- Bachelor of Science degree (or equivalent), preferably in Biomedical, Mechanical or Manufacturing Engineering with 3-6 years of related experience.
- General understanding of Good Manufacturing Practices, FDA regulations, and ISO requirements.
- Experience with process and equipment validations/qualifications.
Required Knowledge, Skills and Abilities
- Experienced with laboratory physical testing methods Validation/Verification
- Process Validation/Verification
- Knowledge with the following systems: CAPA, Risk Management, Design Controls and Change Management
- Must have strong technical and analytical ability; detail oriented.
- Must have good verbal and written communication skills.
- Strong interpersonal skills.
- Good organizational skills. Must be able to adhere to timelines.
- Knowledge of computer skills including, but not limited to: Microsoft Windows, Word, Excel, Project, PowerPoint, Teams, Solidworks
- Basic understanding of statistical analysis.
Salary range: $94,000.00 - $97,000.00
#LI-LG1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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.
Job Overview
The Project Manager will be responsible for the leadership of complex cross-functional projects related to the development and/or sustainment of electro-mechanical medical device systems and/or single use catheters. Project assignment is at the discretion of the supervisor and is based on business requirements. Also responsible for all phases of the project, from Concept Development to Product Launch. Develop and drive project timelines, assemble required project teams, track schedule and deliverables, and maintain effective communication throughout the project.
Job Responsibilities and Essential Duties
- Lead cross-functional project teams in support of Class I - III medical devices.
- Monitor and maintain awareness of new and current product regulations and standards.
- Develop and release all project-related deliverables, including project plan, schedule and budget.
- Manage a project within standardized methods and project models such as Waterfall or Agile
- Lead and support execution of technical and/or cross-functional project work
- Ensure the timely release of critical deliverables within the project.
- Ensure all aspects of the project are in compliance to internal procedures.
- Develop and present periodic status reports.
- Effective communication with project stakeholders, local management, and global management
- Demonstrate leadership when facing uncertainty.
- Understanding of group dynamics to influence team members and lead the project.
- Instill confidence through leadership and actions.
- Identify, support, and promote new concepts and initiatives related to Project Management within the organization.
Minimum Requirements
- BS in Engineering discipline (e.g., Systems, Biomedical, Electrical or Software Engineering) or equivalent experience
- Minimum of 3+ years in project lead role or project management role
- Preferred - experience in medical device or other regulated industry.
- Domestic and/or international travel up to 20%
Required Knowledge, Skills and Abilities
- Experience with Microsoft Project, JIRA, Antura or other project management software
- Experience in leading tasks/projects through a structured, phase-gate process
- Lead and manage technical meetings with cross-functional members.
- Excellent interpersonal, verbal, and written communication skills
- Strong technical writing skills; must be well organized, detail oriented.
- Task oriented and driven to complete assignments on schedule.
- Must have the ability to effectively interface with both technical and non-technical personnel.
- Medical Device experience including thorough understanding of Medical Device Quality Management Systems (ISO 13485, 21 CFR 820, ISO 14971)
- Working knowledge of FDA and International Standards requirements as related to capital equipment and disposables.
Salary range: $120k - $140k
#LI-LG1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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.
Job Responsibilities and Essential Duties
- Lead and govern design-related CAPA activities across the R&D organization, ensuring timely, compliant, and effective resolution of complex design, verification, validation, and product performance issues.
- Oversee and review root cause investigations using rigorous, data-driven problem-solving methodologies, and ensure corrective and preventive actions are appropriately scoped, risk-based, sustainable, and effectively linked to design controls, risk management, and product lifecycle processes.
- Ensure CAPA records and documentation are complete, accurate, and audit-ready, in compliance with FDA regulations, ISO 13485, and internal quality system requirements.
- Manage and develop the R&D CAPA team, including setting expectations, prioritizing
- workload, providing technical direction, and coaching CAPA specialists and engineers.
- Provide technical guidance, coaching, and mentorship to R&D engineers and CAPA owners on CAPA processes, best practices, timeline development, SOP adherence, and effectiveness verification planning.
- Serve as the primary R&D CAPA interface with Quality, Regulatory Affairs, Operations, and other cross-functional partners to address systemic and cross-product issues.
- Review and approve CAPA plans, timelines, effectiveness verification strategies, and closure rationales to ensure regulatory robustness and high-quality outcomes.
- Support internal and external audits, inspections, and assessments by providing CAPA documentation (e.g., CAPA storyboards), investigation rationale, and subject matter expertise.
- Act as a CAPA subject matter expert within the R&D organization, driving continuous improvement in CAPA execution quality and consistency.
Minimum Requirements
- Bachelor's degree in Engineering or related technical field; advanced degree preferred.
- 6+ years of experience in R&D within a medical device organization with at least 5 years of CAPA processes and regulatory compliance requirements (FDA, ISO 13485).
- 2+ years of leadership experience managing engineering teams.
- Proven experience in managing CAPA for design and development activities
Required Knowledge, Skills and Abilities
- Expert-level understanding of CAPA methodologies, root cause analysis tools (Fishbone, 5 Whys, FMEA), and risk management.
- Strong leadership and team management skills with ability to influence and drive accountability.
- Excellent analytical and problem-solving abilities with attention to detail.
- Effective communication and presentation skills for all organizational levels.
- Experience with drafting statistically sound sampling plans & acceptance criteria for measuring Effectiveness of implemented actions.
- Proficiency in documentation and electronic CAPA systems, Trackwise preferred.
- Deep knowledge of medical device regulations and design control requirements.
Salary range: $145k - $175k
#LI-LG1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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.
JobOverview
The Staff Engineer, Sustainabilityleads sustainability initiatives across product development, operations, and supply chain whileestablishinggovernance frameworks. It ensures measurable environmental impact reductions, compliance with FDA/ISO standards, and trusted performance metrics aligned with business strategy.
Job Responsibilities and Essential Duties
Drive carbon reduction roadmap and eco-design principles.
Lead lifecycle assessments and integrate sustainability into product development.
Collaborate with suppliers on low-carbon initiatives.
Support compliance with ISO 14001, ISO 14040, and FDA standards.
Ensure raw material complianceto include RoHS, REACH, EU MDR Prop65
Define and standardizegovernance & KPI'sacross teams.
Ensure data integrity and consistent reporting.
Build dashboards to track sustainability and performance KPIs.
Review and updategovernanceto align with evolving strategies.
MinimumRequirements
Degree in Engineering, Sustainability,Project Management,or Data&Analytics.
7+years in sustainability, governance, or regulated environments.
Knowledge of lifecycle assessment, ISO frameworks, and BI tools (Power BI, Tableau).
Strong communication, stakeholder management, and analytical skills.
PMP Certification a plus.
Salary range: $98,000.00 - $125,000.00 plus bonus targeted at 10% (depending on overall company performance)
#LI-LG1
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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.
Job Overview
The Sr. R&D Engineer - CAPA Specialist is a senior individual contributor responsible for leading complex, design and/or R&D controlled QMS process related Corrective and Preventive Action (CAPA) investigations within the Research & Development organization. This role drives robust root cause analysis, corrective and preventive action development, and effectiveness verification to ensure product quality, regulatory compliance, and continuous improvement in design and development processes.
Operating with a high degree of autonomy, this position serves as a technical authority and trusted advisor to R&D teams, providing guidance on structured problem-solving, CAPA best practices, and regulatory expectations. While the role does not include people management responsibilities, it plays a critical mentoring and coaching role within the R&D CAPA ecosystem.
Job Responsibilities and Essential Duties
- Lead and execute product design and or Design Controls process related CAPA investigations within the R&D organization, from problem definition through implementation and effectiveness verification.
- Perform thorough and structured root cause analyses for design, verification, validation, and product performance issues using appropriate analytical tools and data.
- Develop and drive robust corrective and preventive actions that are risk-based, technically sound, and aligned with design controls and risk management processes.
- Ensure CAPA documentation is accurate, complete, and compliant with FDA regulations, ISO 13485, and internal quality system requirements.
- Collaborate closely with cross-functional partners-including Quality, Regulatory Affairs, Operations, and Manufacturing Engineering-to address systemic and cross-functional issues.
- Provide technical guidance, coaching, and informal mentorship to R&D engineers and associates on CAPA processes, problem-solving methodologies, and regulatory expectations.
- Support CAPA owners in developing realistic timelines, following CAPA SOPs, and defining appropriate effectiveness verification plans and acceptance criteria.
- Support internal and external audits and inspections by providing CAPA documentation, investigation rationale, and technical explanations.
- Maintain clear traceability between CAPA investigations, corrective actions, effectiveness checks, and related design and risk documentation.
- Identify opportunities to improve CAPA execution quality and efficiency and contribute to broader quality system and R&D process improvements.
- Serve as a technical CAPA subject matter expert within the R&D organization.
Minimum Requirements
- Bachelor's degree in Engineering or related technical discipline; advanced degree preferred.
- 5+ years of experience in R&D engineering within a medical device organization.
- Demonstrated experience managing and executing CAPA activities within product design and development.
- Strong understanding of regulatory requirements, including FDA regulations and ISO 13485.
Required Knowledge, Skills and Abilities
- Expert-level knowledge of CAPA methodologies and root cause analysis tools (e.g., Fishbone, 5 Whys, FMEA) and risk management practices.
- Strong analytical and problemsolving skills with exceptional attention to detail.
- Ability to provide clear technical guidance and support to junior engineers without direct supervisory responsibility.
- Effective verbal and written communication skills for presenting findings across all organizational levels.
- Experience creating statistically sound sampling plans and acceptance criteria for effectiveness verification.
- Proficiency with CAPA and documentation systems; TrackWise experience preferred.
- Indepth knowledge of medical device regulations, design control processes, and quality system expectations.
Salary Range: $115k - $140k
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge:
At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Location: Newark, NJ (Hybrid)/Fort Washington, PA (Hybrid)
Duration: 12 Months
Job Description:
We are seeking a highly skilled and experienced Business Analyst with a background in implementing effective contact center/IVR solutions. The ideal candidate will have a proven track record in supporting AI-driven transformations in the IVR and chatbot space. This role requires a deep understanding of customer service operations, actionable business intelligence, data modeling, and governance, especially within the financial services industry.
Key Responsibilities:
* Experience in modernizing IVR flows into customer-centric, adaptive, and learning-oriented conversational journeys powered by AI agents.
* Ability to capture and translate business needs into agentic AI-focused requirements, shifting from traditional deterministic IVR call flow logic to flexible, goal oriented conversational behaviors.
* Evaluate business processes, anticipate requirements, and uncover areas for improvement ensuring strategic alignment and operational efficiency.
* Develop actionable business intelligence and analytics to drive decision-making.
* Lead ongoing reviews of business processes and developing optimization strategies.
* Develop and implement data governance, data management, and data quality program practices and strategies.
* Model business processes for Interactive Voice Response (IVR) and implement effective solutions.
* Foster a culture of continuous improvement and excellence.
What you bring to the table:
* Demonstrated experience in redesigning IVR systems (for self-service on the voice channel) and leveraging AI solutions in the IVR space.
* Experience working in an AGILE environment.
* Strong analytical skills and proficiency in data modeling techniques.
* BA/BS in CS, Information Systems or Information management or Systems design.
* Ability to manage complex projects and deliver results in a fast-paced environment.
* Excellent communication and leadership abilities.
Bonus if you have:
* Deep expertise in insurance financial engines and regulatory compliance.
* Knowledge of SQL, Databases and Analytical/Reporting tools such as PowerBI/Tableau.
Location: Remote
Duration: 6 months
Role Overview
The Integration Architect defines, designs, and governs enterprise integration architecture standards across AWS, Azure, Microsoft Fabric, and on-prem systems. This consultant creates scalable integration blueprints, reusable patterns, and secure connectivity frameworks that ensure interoperability, reliability, and domain-aligned data exchange. The role partners closely with domain teams, platform engineering, API management teams, and enterprise architecture to accelerate delivery while maintaining architectural integrity.
Key Responsibilities
Integration Standards & Governance
- Define and maintain enterprise standards for API design, event schemas, messaging patterns, and integration of contracts.
- Establish integration governance across AWS, Azure, MS Fabric, and on-prem systems.
- Define patterns for ADS (Authorized Data Sources) alignment, data contracts, schema evolution, and anchor key management.
- Enforce adherence to enterprise security principles, including OAuth2/OIDC, JWT, TLS, Zero Trust patterns.
Blueprints & Reference Architecture
- Build and maintain unified enterprise integration architecture blueprints spanning cloud, Fabric, and on prem connectivity.
- Create domain specific and cross domain integration flow maps, canonical API patterns, and event driven reference architectures.
- Align AWS, Azure, MS Fabric, and on-prem patterns under Unified Architecture.
Reusable Patterns & Engineering Enablement
- Develop reusable integration patterns for:
- AWS: API Gateway, Event Bridge, SNS/SQS, Lambda, Step Functions, Glue, EMR, Redshift, Lake Formation, Kinesis, AWS Batch, AWS ECR, AWS ECS Fargate.
- Azure: APIM, Functions, Service Bus, Azure Data Factory (all IR types), Azure Synapse Pipelines, Azure Stream Analytics, Azure Batch, Azure Data Explorer ingestion.
- MS Fabric: Data Factory pipelines, Lakehouse ingestion interfaces, Fabric Data Pipelines, Notebook-based ETL, Warehouse ingestion.
- On prem: MFT, MQ, legacy services.
- Provide templates for API contracts, event schemas, integration error handling, observability hooks, and resiliency patterns.
Metadata, ADS, & Anchor Key Integration
- Define integration patterns incorporating ADS rules, domain ownership, and anchor key management for interoperability.
- Ensure all integration patterns embed security, observability, lineage awareness, and operational resiliency.
- Collaborate with data governance to ensure consistent entity resolution and cross?domain identifier mapping.
Domain Engagement & Architecture Review
- Guide domain teams in implementing target state integration architectures.
- Lead or participate in architecture reviews for API designs, event models, platform integrations, and connectivity.
- Recommend modernization opportunities to retire from legacy integration mechanisms and adopt event-driven/API?first models.
Qualifications
Technical Expertise
- 8-12+ years in integration architecture, API engineering, event-driven design, or hybrid integration.
- Strong hands-on expertise across:
- AWS: API Gateway, Event Bridge, SNS/SQS, Lambda, Step Functions, Glue, EMR, Redshift, Lake Formation, Kinesis, AWS Batch, AWS ECR, AWS ECS Fargate.
- Azure: APIM, Functions, Service Bus, Azure Data Factory (all IR types), Azure Synapse Pipelines, Azure Stream Analytics, Azure Batch, Azure Data Explorer ingestion.
- MS Fabric: Data Factory pipelines, Lakehouse ingestion interfaces, Fabric Data Pipelines, Notebook-based ETL, Warehouse ingestion.
- RDBMS: SQL, Oracle, DB2, RDS, etc.
- On prem: MQ, MFT, REST/SOAP services.
- Understanding of ADS, anchor key management, data/domain contracts, lineage aware integration.
- Experience designing event driven, API first, batch, and hybrid integration architectures.
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.
Job Overview
The Quality Engineer I Quality Operations specializes in Quality Operations, and is responsible for overseeing and improving the quality of manufacturing processes, ensuring compliance with regulatory requirements, and driving continuous improvement initiatives to enhance product quality and customer satisfaction. You will play a key role in ensuring that our manufacturing operations meet the highest standards of quality and efficiency while adhering to relevant regulations and industry best practices.
Job Responsibilities and Essential Duties
- Develop, implement, and maintain quality control processes and procedures for manufacturing operations to ensure compliance with regulatory requirements and industry standards.
- Establish and monitor key performance indicators (KPIs) to assess manufacturing quality and identify opportunities for improvement.
- Participate/ Lead validation and verification activities for manufacturing processes, equipment, and software systems to ensure they meet quality and regulatory requirements.
- Develop/ review validation protocols, execute validation studies, and analyze data to ensure process robustness and reliability.
- Ensures through Design Transfer activities the Device Master Records (DMRs) contents are developed, controlled, and maintained leading to Risk based Manufacturing Control Plans.
- Support/ Investigate and resolve Out of Tolerance events identified during equipment/ instrument calibrations.
- Investigate product nonconformances, conduct root cause analysis, and implement corrective and preventive actions (CAPA).
- Track and monitor CAPA effectiveness to ensure issues are resolved and prevented.
- Support the Health and Hazard Evaluation process by gathering required data and performing in-depth analysis prior to sharing the information with the Field Action Committee.
- Implement corrective and preventive actions (CAPAs) to address root causes and prevent recurrence of quality issues.
- Facilitate risk management activities related to manufacturing processes, identifying, and mitigating risks to product quality, safety, and efficacy.
- Implement risk-based decision-making processes to prioritize quality activities and allocate resources effectively.
- Lead and support continuous improvement projects aimed at enhancing manufacturing processes, reducing defects, and optimizing productivity.
- Utilize quality tools and methodologies, such as Six Sigma, Lean Manufacturing, and Statistical Process Control (SPC), to drive process optimization and waste reduction.
- Ensure compliance with applicable regulations, including FDA Quality System Regulation (QSR), ISO 13485, and other international standards.
- Support both internal and external audits as an SME for Production & Process Controls and presents records of activities related to Design Transfer for New Product Development and Design Changes.
Minimum Requirements
- Bachelor's degree in engineering, Science, or other related field is required.
- Six Sigma Green Belt or other applicable certifications are a plus.
- Minimum 1 year experience in Quality or Engineering.
- Experience in a medical device or pharmaceutical industry.
- Experience with Class III disposable and/or Electro-Mechanical medical devices is preferred.
- Knowledge and understanding of the US Food and Drug Administration (FDA) 21 CFR 820, ISO 13485, ISO 14971, EU MDD, and EU MDR. Knowledgeable on specific requirements for Design Controls and Risk Management is preferred.
- Knowledge of application & selection of Sampling Plans, to support Risk based Manufacturing Controls Plans.
- Project management and leadership experience is desirable.
- Knowledge of Microsoft Office Products such as Word, Excel, or equivalent software applications.
Required Knowledge, Skills and Abilities
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Proficiency in quality tools and methodologies (e.g., Six Sigma, FMEA, Gage R&R).
- Ability to work effectively in a cross-functional team environment.
- Ability to review and understand technical standards and their requirements for products.
- Lead improvement initiatives, either independently or as part of cross-functional teams
The base salary for this the position is a minimum salary of $87,000 and a maximum of $90,000 with 8% annual bonus
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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What to Expect
Information Professional Officer
More Information
Responsibilities
Information Professional Officers (IPOs) oversee the seamless operation of the global Naval network environment. Their responsibilities include:
- Leading the Naval network warfare missions in developing tactics and procedures to realize tactical, strategic and business advantages afloat and ashore
- Driving interoperability with joint, allied and coalition partners
- Building professional excellence through education, training and certification and milestone qualifications
- Optimizing organizational effectiveness through cutting-edge technologies, knowledge management techniques and a culture of innovation
- Helping to develop and deploy information systems, command and control and space systems
- Serving as a key part of the Information Dominance Corps in its mission to gain a deep understanding of the inner workings of adversaries
- Overseeing the work of Information Systems Technicians - Enlisted Sailors (no degree required) who serve as specialists in information technology
Work Environment
Information Professionals serve in challenging roles of increasing scope and responsibility both afloat and ashore. This could include:
- Serving as part of Battle Group staffs on ships at sea
- Working in C4I/Space/Surveillance on shore tours
- Serving on major Navy and joint staffs
- Serving in command of key communication and surveillance facilities around the globe
Training & Advancement
Those pursuing an Information Professional Officer position are required to attend Officer Candidate School (OCS) in Newport, RI.
Upon completion, candidates typically attend a five-week IP Basic Course of instruction in Pensacola, FL, before or during their initial assignment. IPOs must complete specific qualifications as part of their training during Fleet tours and are expected to pursue advanced education opportunities.
Promotion opportunities are regularly available but competitive and based on performance.
Post-Service Opportunities
Specialized training received and work experience gained in the course of service can lead to valuable credentialing and occupational opportunities in related fields in the civilian sector.
Education Opportunities
Wherever you are in your professional career, the Navy can help ease your financial burdens and advance your career with generous financial assistance and continuing education programs. Beyond professional credentials and certifications, Information Professional Officers can advance their education by:
- Pursuing opportunities at institutions such as Naval Postgraduate School (NPS) or Navy War College (NWC)
- Completing Joint Professional Military Education (JPME) at one of the various service colleges
Postgraduate education is important to the success of the Information Professional. Most IPs will complete a master's degree in C4I, space, information systems, computer science or modeling and simulation.
There's also potential to pursue a graduate certificate, DoW certifications, federal executive fellowships and information assurance scholarships and internships.
Qualifications & Requirements
A degree from a four-year college or university is a minimum educational requirement to become a Commissioned Officer. Candidates seeking an Information Professional Officer position must have a bachelor's degree from a regionally accredited institution in a technical field, preferably in one of following fields: Information Systems, Electrical Engineering, Computer Engineering, Information Operations, Computer Science, Systems Engineering, General Engineering.
All candidates must also be: U.S. citizens, willing to serve worldwide, eligible for a Top Secret/Sensitive Compartmented Information (SCI) security clearance and qualified for sea duty.
General qualifications may vary depending upon whether you're currently serving, whether you've served before or whether you've never served before.
Part-Time Opportunities
There are part-time opportunities available as an Information Professional Officer.
Serving part-time as a Navy Reserve Sailor, your duties will be carried out during your scheduled drilling and training periods. During monthly drilling, Information Professional Officers in the Navy Reserve typically work at a location close to their homes.
For annual training, Information Professional Officers may serve anywhere in the world, whether on a ship at sea or at bases and installations on shore.
Take a moment to learn more about the general roles and responsibilities of Navy Reserve Sailors.
Most of what you do in the Navy Reserve is considered training. The basic Navy Reserve commitment involves training a minimum of one weekend a month (referred to as drilling) and two weeks a year (referred to as Annual Training) - or the equivalent of that.
Information Professional Officers in the Navy Reserve serve in an Officer role. Before receiving the ongoing professional training that comes with this job, initial training requirements must first be met.
For current or former Navy Officers (NAVET): Prior experience satisfies the initial leadership training requirement - so you will not need to go through Officer Training again.
Officers who previously held a commission in another United States Military Service, National Oceanic and Atmospheric Administration, Public Health Service, or United States Coast Guard are exempt from attending ODS or LDO/CWO Academy.
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