Principal Compliance Engineer - EMI/EMC/Electrical Safety

Werfen • Bedford, MA

3d

About The Position

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Job Summary
The Principal Compliance Engineer is the Hemostasis and Acute Care Dx business units’ technical authority for EMI, EMC, and Electrical Safety. Candidate ensures timely planning, execution, and monitoring of compliance-implementation. As a member of the Life-Cycle Engineering (LCE) team (also known as Engineering Shared Services), individual partners with Regulatory and Quality Depts. to ensure instrumentation portfolio(s) remain compliant throughout the entire product lifecycle.
This individual contributor role operates with delegated decision authority to define compliance-implementation strategy, adjudicate internal and external standards interpretation, and establish defensible technical positions for global market access across Hemostasis and Acute Care Diagnostics products
The Principal Compliance Engineer is a recognized subject matter expert (SME) who influences compliance policy, manages consistent execution across programs and sites, influences international standards development, and partners with Regulatory and Quality organizations to ensure long term regulatory readiness, audit defensibility, and lifecycle sustainability.

Requirements

• Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or related field (advanced degree preferred).
• 10+ years of progressively responsible experience in EMI, EMC, and Electrical Safety compliance for regulated electronic products.
• Demonstrated mastery of IEC 61326, IEC 61010 series, IEC 60601 1 2, and RED requirements, including defensible interpretation and application.
• Proven experience representing an organization externally with regulators, notified bodies, auditors and/or standards organizations.
• Exceptional technical judgment, written communication, and ability to influence high-stakes, cross-functional decisions.
• Recognized expert-level knowledge of EMI/EMC and electrical safety principles, test meth-ods, and failure mechanisms for regulated electronic products.
• Proficiency interpreting and applying key standards/regulations (e.g., IEC 61326, IEC 61010 series, IEC 60601-1-2, RED) and documenting defensible positions.
• Ability to translate requirements into practical design rules, verification plans, and pass/fail criteria.
• Strong technical judgment and risk-based decision-making (including interfaces to product risk management and change control).
• Maintain hands-on technical capability to troubleshoot complex EMC and safety failures as needed, while operating at a system- and portfolio-levl to guide design decision, test strategy, and corrective actions across programs.
• Experience leading external lab engagements (test strategy, scheduling, witnessing, devia-tions, retest scope).
• Ability to develop and maintain compliance evidence (plans, reports, rationales) suitable for submissions and audits.
• Clear technical communication (written and verbal) to influence stakeholders and explain complex issues simply.
• Stakeholder management and negotiation skills to resolve conflicts among cost, schedule, performance, and compliance.
• Mentoring and knowledge-sharing capability to raise compliance maturity across teams and sites.

Nice To Haves

• Active or prior membership on IEC or equivalent standards authoring committees.
• Medical device and/or IVD instrumentation experience.
• Experience defining or governing enterprise or portfolio-level compliance strategy across multiple product lines.
• Demonstrated experience defending compliance position during audits or regulatory review.
• Deep knowledge of risk management interfaces (ISO 14971 context).
• Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Responsibilities

• Establish, maintain, and lead EMI/EMC and Electrical Safety compliance strategy for In-strumentation Hardware across the Hemostasis and Acute Care Diagnostics product port-folio and full lifecycle (NPD through sustaining).
• Serve as the technical authority for standards interpretation, risk based decisions, retest versus justification determinations, and disputed compliance positions. Approve defensible technical rationales in alignment with Regulatory and Quality leadership.
• Partner with Regulatory and Quality organizations to define and govern internal compli-ance policies, standards applicability guidance, and design/test expectations aligned to ap-plicable regulations and standards (e.g., IEC 61326, IEC 61010 series, IEC 60601 1 2, RED).
• Define, approve, and establish portfolio wide criteria for retesting versus technical justifi-cation (analysis, similarity, historical evidence, and risk based rationale) and ensure con-sistent application across sites and programs.
• Anticipate regulatory and standards evolution; build and maintain long term compliance roadmaps addressing transitions, obsolescence impacts, and platform reuse or harmoniza-tion strategies.
• Ensure compliance strategy is integrated into product architectures and formal change control by partnering with R&D, Quality, Regulatory, and Operations on high impact design and lifecycle decisions.
• Lead technical compliance position in interactions with external test laboratories, notified bodies, auditors, and regulators, including test strategy definition, deviation resolution, regulatory inquiries, surveillance activities, and investigation support.
• Represent Werfen in external standards committees, working groups, and industry forums; contribute to and influence emerging requirements in alignment with product and technol-ogy strategy.
• Own the quality of compliance technical files and objective evidence (plans, reports, ra-tionales) to support submissions and lifecycle maintenance.
• Build organizational compliance capability by mentoring engineers, delivering targeted training, and governing knowledge management for EMI/EMC and electrical safety across the enterprise.
• Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Benefits

• If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
• Werfen is an Equal Opportunity employer and is committed to a diverse workplace.
• Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law.
• If you have a disability and need an accommodation in relation to the online application process, please contact [email protected] for assistance.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal