Engineering Jobs in Wanaque New Jersey

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

Effectively design, develop, and document medical devices and medical equipment that satisfy internal and external customer needs and business objectives.

Job Responsibilities and Essential Duties

* Interprets customer specifications to define requirements for mechanical designs.

* Performs first principal analysis related to appropriate aspects of mechanical design.

* Provide support to peers, Jr Engineers, and Co-Ops.

* Applies the 3D CAD system to create mechanical design and drawings.

* Develops detailed fabrication and assembly drawings and performs tolerance analysis.

* Develop prototypes for design evaluation.

* Troubleshoot and resolve design & processing issues.

* Contributes to details of design documentation using electronic documentation systems.

* Collects, analyzes, and interprets data to propose recommendations.

* Develops & execute design verification protocols and technical reports.

* Work with internal and external resources on fabrication, inspection, and testing of new product parts and assemblies.

* Develop & debug prototype tooling / equipment and processes.

* Develop test methods and fixtures.

* Formulate plans & methods to accomplish assignments with appropriate oversight.

* Works independently and prioritizes assigned tasks with guidance.

* Contribute to project planning activities.

* Train technicians and operators on new process techniques.

Minimum Requirements

* BS in engineering discipline, mechanical preferred.

* Minimum 2-4 years related experience, or an MS and less than one year experience.

* Experience with a solid modeling CAD program, preferably SolidWorks and/or ProE.

* Experience in medical equipment / device design with experience in electromechanical, electro- pneumatic, and/or blood pumping equipment development.

* Knowledge in medical device industry regulations and practices - ISO 13485, ISO 7198 & GMP.

* Proficiency with Microsoft Windows, MS Office applications, and Adobe Acrobat.

* Experience with Microsoft Visio and Microsoft Project preferred.

Required Knowledge, Skills, and Abilities

* Design for Manufacturability and Assembly, DFM&A (cost/tooling/process considerations), preferably using SolidWorks CAD software.

* Understanding in design and development of injection molded plastic, plastic extrusion, casting, sheet metal, metal stampings, additive manufacturing processes, and machined metal components, and assemblies with high part counts highly desirable.

* Knowledge of mechanical design and development using metric ANSI/ISO dimensioning and drafting standards highly desirable.

* Understanding of GD&T, mechanical measurement and testing equip., and statistical analysis of test data.

* Experience with electronic document control systems in medical device and/or medical equipment design and development.

* Highly skilled at analytical reasoning, mechanism design, creative problem solving, and mathematical analysis.

* Ability to create and meet scheduled timelines (manage and coordinate tasks as required).

* Ability to work in a team environment.

* Strong communication skills.

* Competent in use of Microsoft Office tools.

* Ability to operate test equipment such as various pressure and flow measurement equipment, temperature/humidity chambers, PC-based data recorders, simulators, DVM's and oscilloscopes.

* Familiarity and the ability to operate basic shop equipment such as hand tools, a drill and Dremel.

* Understand and interpret simple wiring diagrams.

* Familiarity with Agile Scrum and waterfall project planning methods

This is a "Defined Term" assignment that will last approximately 6 months or until project is complete. Defined Term employees are eligible for most benefits (including health insurance and paid time off) while on assignment.

#LI-AS1

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
  

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 Manager, Collagen Operations serves as the sole site leader for the Mahwah, NJ Collagen facility and carries full responsibility for all site personnel decisions, site performance, and operational escalations. This role ensures the safe, compliant, and efficient operation of the site while driving a strong culture of quality, engagement, and continuous improvement.

This position is accountable for the implementation of operational strategy as defined by the Getinge France (La Ciotat) leadership team. The Manager must ensure that all production activities adhere to U.S. regulatory protocols, including FDA, ISO, GMP, ESD, and Medical Device requirements, while also ensuring that all U.S. people practices (HR, safety, compliance, labor standards) are fully adopted and consistently upheld.

The Manager leads the site in achieving production, safety, quality, and delivery objectives while ensuring strong communication, alignment, and reporting back to the Getinge France entity.

Key Responsibilities

Site Leadership & Escalations

Serve as the highest-ranking leader on-site, responsible for daily operational oversight.

Act as the primary escalation point for all personnel, safety, compliance, and operational matters.

Maintain a proactive presence on the production floor; ensure alignment between site activities and La Ciotat leadership direction.

Lead all site-level communication, engagement efforts, and leadership routines.

Safety, Quality & Compliance

Serve as the site owner for safety, quality, and environmental compliance.

Ensure strict adherence to all U.S. regulatory requirements, including FDA, ISO, GMP, ESD, environmental, and medical device standards.

Ensure all U.S. people practices-including investigations, corrective action processes, documentation, training standards, and HR compliance-are consistently applied.

Guarantee timely and effective management of nonconformances, CAPAs, and deviations; lead site-level reviews and escalations.

Operations Management

Lead the execution of the annual production plan and ensure on-time delivery in alignment with customer needs and La Ciotat directives.

Oversee production scheduling, resource planning, inventory management, and staffing decisions.

Ensure production equipment, cleanroom environments, and facilities are properly maintained and audit-ready.

Manage manufacturing engineering and support functions to drive continuous improvement, cost savings, and process optimization.

Ensure documentation accuracy and compliance, including SOPs, controlled documents, training records, and batch documentation.

People Leadership

Full responsibility for all site personnel management, including hiring, onboarding, development, coaching, performance management, and employee relations.

Drive a culture of engagement, teamwork, and accountability consistent with Getinge values and U.S. people practices.

Set clear objectives, oversee workload planning, conduct performance reviews, and support career development.

Cross-Functional & Global Collaboration

Collaborate closely with the La Ciotat Production Director and France-based teams to ensure alignment on operational execution, reporting, and strategy.

Partner with U.S.-based HR, Quality, EHS, Engineering, and Supply Chain teams to ensure compliance and best practices across all site functions.

Coordinate validation, feasibility builds, technical projects, and operational readiness with sustaining engineering and global partners.

Essential Duties

Organize and manage site production resources to meet daily, weekly, and annual plans.

Anticipate operational needs and align staffing with forecasts.

Define short-term production plans compatible with demand and capacity.

Lead investigations into deviations, failures, or operational issues and implement corrective actions.

Oversee preventive and corrective maintenance and technical shutdowns.

Submit and manage investment requests to support operational goals.

Ensure all personnel comply with safety rules, gowning, cleanroom regulations, and quality protocols.

Maintain readiness for internal and external audits at all times.

Minimum Requirements

High school diploma required; advanced education preferred.

3-5 years of experience as a production manager in medical device or similarly regulated environment.

Experience in cleanroom or controlled environment operations preferred.

Demonstrated ability to lead teams and run a manufacturing site with a high level of autonomy.

Strong computer skills; SAP experience a plus.

Targeted salary range: $138,000- $145,000, depending upon experience and location +15% bonus target

#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:

This position performs installation, maintenance, and repairs of computer driven electro-mechanical production equipment, ensuring that all related quality documentation is executed, while reviewing maintenance procedures for effectiveness.

Job Responsibilities and Essential Duties:

* Maintenance and repair of computer driven electro-mechanical manufacturing equipment in support of medical device production.

o Computer driven systems include proportional-integral-derivative (PID) operating controllers, programmable logic controllers (PLCs), and Human Machine Interface (HMI) automation.

o Sub-systems and components include electric drives, motors, electrical wiring, hydraulics, pneumatics, electrical panels, relays, printed circuit board circuitry, vacuum, and compressed air.

* Respond to emergency repair requests through troubleshooting, diagnosis, resumption of operation, and electronic documentation.

* Execute preventative/scheduled maintenance including planning of materials, parts, training, and other requirements to ensure work is executed in an efficient and timely manner.

* Document all work planned and performed in the computerized maintenance management system.

* Evaluate operation of equipment and instruments to conduct on-line adjustments. * Evaluate, quote, and order necessary replacement equipment, tools, and fixtures. * May develop or revise documents and procedures.

* Build Quality into all aspects of their work by maintaining compliance to all quality requirements.

Minimum Requirements :

* A high school diploma or equivalent is required. An associate degree or equivalent years of experience in Engineering, Science or related technical field is preferred

* 1-3 years of technician experience in a manufacturing environment is required; experience working in medical device manufacturing or other FDA regulated industry preferred.

Required Knowledge, Skills, and Abilities :

* Ability to read wiring diagrams, schematics, and plumbing diagrams to expertly troubleshoot electro-mechanical equipment, electric drives, motors, basic wiring, hydraulics, and pneumatics is required.

* Working knowledge of flow controls, valve selection, and pressure regulation.

* Must demonstrate effective verbal and written communication skills.

* Must be well organized and demonstrate the ability to work independently and manage multiple tasks and priorities.

* Must be flexible and demonstrate the ability to take initiative.

* Working knowledge of equipment powered by 120, 208/230, and 480VAC electrical voltage is required.

* Experience with PLC/HMI and MS-DOS programming languages is preferred.

* Proficiency with Microsoft Office products such as Word and Excel or equivalent software applications is preferred.

The pay for this role is a minimum of $25 per hour ($52k/yr) and a maximum of $33 per hour ($68,640/yr).

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 Complaint Engineer I conducts complaint investigations to identify causes of reported product defects. The role analyzes complaint data to detect undesirable trends and performs escalation request to drive effective corrective actions. It collaborates crossfunctionally to support timely resolution of product issues and support corrective and preventive actions.

Job Responsibilities and Essential Duties

• 
  
• Perform complaint investigations to determine potential cause(s). This includes evaluating field-reported information, reviewing applicable risk assessments, instructions for use (IFU), trend data, and other relevant documentation. The primary goal is to determine possible failure mechanisms and contributing factors related to the reported issue
  
• Initiate, own and support Corrective and/or Preventive Actions
  
• Perform daily, weekly, monthly data analysis of complaints to identify adverse trends
  
• This is not an inclusive list of job responsibilities
  

Required Knowledge, Skills and Abilities

• 
  
• Bachelor's degree in biomedical engineering, Mechanical Engineering, Electrical Engineering, or related technical discipline.
  
• Minimum of 1 year experience in complaint handling and complaint investigations for medical devices.
  
• General understanding of Good Manufacturing Practices, good Documentation Practices FDA regulations, and ISO requirements.
  
• Experience with Complaint, Corrective and Preventive Actions, Field Actions processes.
  
• Experienced with handling Biohazard materials.
  

• 
  
• Experience with laboratory work in the medical devices industry.
  
• Proficient in Microsoft Office Suite (Power Bi, Excel, Word, Outlook)
  
• Excellent written and verbal communication skills.
  
• Strong problem-solving skills and a passion for investigation and root cause analysis
  
• Strong interpersonal skills.
  
• Good organizational skills. Must be able to adhere to timelines.
  
• Basic understanding of statistical analysis.
  
• Basic understanding of quality systems
  

The base salary for the position is a minimum salary of 85,000 and a maximum of 90,000, plus 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.

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

To support CS Manufacturing and support the manufacturing engineering department.

Job Responsibilities and Essential Duties

• 
  
• Observes and complies with all safety rules and regulations. This includes QSR and ISO Standards.
  
• Participates in Material Review Boards (MRB) Decision process.
  
• Identifies and implements corrective actions for manufacturing related issues.
  
• Performs equipment setup and corrective, preventative and calibration maintenance as necessary.
  
• Installs and validates equipment and processes in the production area to improve yield and/or reduce cycle time following the established validation procedure.
  
• Evaluate operating data to conduct on-line adjustments to products, instruments, or equipment. May develop or revise documents and procedures.
  
• Certifies manufacturing associates in the production processes.
  
• Evaluates and orders necessary equipment, tools, and fixtures.
  

Minimum Requirements

• 
  
• A high school diploma or equivalent is required. Associate Degree in Engineering, Science or related technical field is preferred.
  
• One to three years of technician experience in a manufacturing environment is required; Experience working in medical device manufacturing or other FDA regulated industry would be ideal.
  

Required Knowledge, Skills, and Abilities

• 
  
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
  
• Must demonstrate effective verbal and written communication skills.
  
• Must be well organized and demonstrate the ability to work independently and manage multiple tasks and priorities. Must be flexible and demonstrate the ability to take initiative.
  
• Proficiency with Microsoft Office products such as Word and Excel or equivalent software applications is preferred.
  

The compensation range for this position is between $26-$31 per hour depending on experience and location.

#LI-MV1

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 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.