Getinge · 4 days ago
Manager, R&D Engineering CAPA - Wayne, NJ
Wayne, NJ, US
Full-time
Onsite
Senior Level
$145K/yr - $170K/yr
6+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. They are seeking a Manager for R&D Engineering CAPA to lead design-related CAPA activities, ensuring compliance and effective resolution of product performance issues while managing the R&D CAPA team.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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
Qualification
Required
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
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
Benefits
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
Company
Getinge
Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.
10001+ employees
H1B Sponsorship
Getinge has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (2)
2022 (2)
2021 (2)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$539.31M2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO
Leadership Team
C
Christoffer Å.
Chief Information Security Officer
Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
Recent News
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2025-12-19
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