Getinge · 1 day ago
Sr. Engineer, R&D CAPA - Wayne, NJ
Wayne, NJ
Full-time
Onsite
Mid, Senior Level
$115K/yr - $140K/yr
5+ years expGetinge is a company dedicated to making life-saving technology accessible for more people. The Sr. R&D Engineer – CAPA Specialist is responsible for leading complex CAPA investigations and ensuring product quality and regulatory compliance within the R&D organization.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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
Qualification
Required
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
Expert-level knowledge of CAPA methodologies and root cause analysis tools (e.g., Fishbone, 5 Whys, FMEA) and risk management practices
Strong analytical and problem‑solving 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
In‑depth knowledge of medical device regulations, design control processes, and quality system expectations
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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