Manager, R&D Engineering CAPA - Wayne, NJ

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.