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

Getinge•Wayne, NJ

About The Position

The Sr. R D Engineer - CAPA Specialist is a senior individual contributor responsible for leading complex, design and/or R D controlled QMS process related Corrective and Preventive Action (CAPA) investigations within the Research & Development organization. This role drives robust root cause analysis, corrective and preventive action development, and effectiveness verification to ensure product quality, regulatory compliance, and continuous improvement in design and development processes. Operating with a high degree of autonomy, this position serves as a technical authority and trusted advisor to R D teams, providing guidance on structured problem-solving, CAPA best practices, and regulatory expectations. While the role does not include people management responsibilities, it plays a critical mentoring and coaching role within the R D CAPA ecosystem.

Requirements

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.

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.