Sr. Engineer, Compliance - Wayne, NJ

Sr. Engineer, Compliance - Wayne, NJ Date: Apr 21, 2026 Location: Wayne, NJ, US Remote Work: 1-2 days at home (site based) Salary Range: $120k – 135k Job Overview The Senior Compliance Engineer is responsible for ensuring that Cardiac Assist electromechanical medical devices meet all applicable global regulatory, quality, and safety requirements throughout their lifecycle. This role provides technical leadership across product safety, electrical safety, design control compliance, labeling and safety markings, environmental/material compliance (RoHS/REACH), and global market‑access requirements, ensuring products remain aligned with state‑of‑the‑art expectations. The Senior Compliance Engineer serves as a critical interface between Engineering, Quality, Regulatory Affairs, Supplier Quality, and Manufacturing, ensuring that product designs, sustaining engineering activities, and change initiatives remain audit‑defensible, traceable, risk‑based, and compliant across international markets. Responsibilities Lead compliance evaluations for new designs, design changes, sustaining engineering, and remediation activities. Interpret and apply global standards including IEC 60601‑1 series (electrical safety), IEC 60601‑1‑8, IEC 60601‑1‑12, EN 1789, GB 9706 series, UL/CSA, and other applicable international product and safety requirements. Support development and verification of labeling, product safety markings, regional electrical requirements, and market‑specific compliance deliverables (EU MDR, FDA, China, LATAM). Conduct compliance impact assessments during design reviews, ensuring requirements, risks, verifications, and mitigations are aligned with global expectations. Ensure compliance documentation is complete, consistent, and audit‑ready (DHF/Technical File), including traceability, risk management, verification and validation records, and certification artifacts. Provide guidance on environmental and material compliance (RoHS, REACH, China RoHS) and ensure supplier documentation meets regulatory expectations. Support CAPA investigations that require compliance input, including evidence review, standards interpretation, and risk‑based justification. Maintain awareness of emerging regulatory changes and state‑of‑the‑art updates; drive integration into engineering processes and technical documentation, and identify required retesting with recognized third‑party test labs. Support global regulatory submissions (510(k), EU MDR Technical Documentation, and regional registrations) with compliance rationale and evidence. Collaborate with Supplier Quality and Procurement to evaluate compliance of purchased components, including safety‑critical and regulated materials. Support internal and external audits, inspections, and technical inquiries, ensuring timely, accurate, and well‑documented responses. Guide engineering teams in applying compliance principles early in product development to reduce downstream redesign and accelerate global approvals. BS in Systems, Biomedical, Electrical, or Software Engineering with 8+ years of related experience. MS or PhD in Systems, Biomedical, Electrical, or Software Engineering with 6+ years of related experience. Demonstrated experience working with relevant medical device regulatory and product‑safety standards (e.g., IEC 60601‑1, ISO 14971, IEC/ISO environmental testing, labeling requirements, or international certification processes). Required Knowledge, Skills, and Abilities Proven experience supporting compliance evaluation, maintenance, or certification of electromechanical medical devices. Strong understanding of medical electrical safety (IEC 60601‑1 series), product safety principles, risk management (ISO 14971), and global market‑access requirements. Working knowledge of FDA QMSR, ISO 13485, ISO 14971, EU MDR, and related regulatory frameworks. Ability to interpret technical compliance reports (e.g., electrical safety, environmental compliance, risk controls, labeling/marking evaluations), identify gaps, and guide engineering teams toward compliant solutions. Strong analytical and problem‑solving skills with ability to apply risk‑based decision making. Excellent verbal and written communication skills, including preparation of audit‑ready technical documentation. Ability to work cross‑functionally and communicate effectively with engineers, quality, regulatory, suppliers, and certification bodies. Strong organizational skills with the ability to manage multiple priorities in a regulated environment. Ability to participate in and lead technical meetings, design reviews, and compliance‑focused assessments. Benefits Health, Dental, and Vision insurance benefits 401(k) 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 Parental and Caregiver Leave Tuition Reimbursement Equal Opportunity Employer 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. #J-18808-Ljbffr Getinge