Sr. Engineer, R&D CAPA - Wayne, NJ

Getinge•Wayne, NJ

4d•$115,000 - $140,000•Hybrid

About The Position

The Senior R&D Engineer – CAPA Specialist is a senior individual contributor in the Research & Development organization who leads complex Corrective and Preventive Action (CAPA) investigations related to product design and R&D-controlled quality management system processes. The role drives root cause analysis, development of corrective and preventive actions, and effectiveness verification to support product quality, regulatory compliance, and continuous improvement in design and development processes. Working with a high degree of autonomy, the role acts as a technical authority and advisor to R&D teams on structured problem-solving, CAPA practices, and regulatory expectations. It has no people-management responsibilities but includes mentoring and coaching R&D colleagues. The position collaborates with Quality, Regulatory Affairs, Operations, and Manufacturing Engineering, supports audits and inspections, and contributes to improvements in CAPA execution and R&D quality processes.

Requirements

Bachelor’s degree in Engineering or a related technical discipline.
At least 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 such as Fishbone, 5 Whys, and FMEA, as well as 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 organizational levels.
Experience creating statistically sound sampling plans and acceptance criteria for effectiveness verification.
Proficiency with CAPA and documentation systems.
In-depth knowledge of medical device regulations, design control processes, and quality system expectations.

Nice To Haves

Advanced degree.
TrackWise experience.

Responsibilities

Lead and execute product design and Design Controls process-related CAPA investigations within R&D, from problem definition through implementation and effectiveness verification.
Conduct structured root cause analyses for design, verification, validation, and product performance issues using appropriate analytical tools and data.
Develop and drive risk-based, technically sound corrective and preventive actions 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 with 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 methods, and regulatory expectations.
Support CAPA owners in developing realistic timelines, following CAPA SOPs, and defining effectiveness verification plans and acceptance criteria.
Support internal and external audits and inspections by providing CAPA documentation, investigation rationale, and technical explanations.
Maintain 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 quality system and R&D process improvements.
Serve as a technical CAPA subject matter expert within the R&D organization.