Principal Compliance Engineer - EMI​/EMC​/Electrical Safety

Principal Compliance Engineer - EMI/EMC/Electrical Safety

Werfen - Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States

Country

United States

Shift

1st

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.

• Establish, maintain, and lead EMI/EMC and Electrical Safety compliance strategy for Instrumentation Hardware across the Hemostasis and Acute Care Diagnostics product portfolio 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 compliance policies, standards applicability guidance, and design/test expectations aligned to applicable 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 justification (analysis, similarity, historical evidence, and risk‑based rationale) and ensure consistent 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 harmonization 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 technology strategy.
• Own the quality of compliance technical files and objective evidence (plans, reports, rationales) 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.

• Manufacturing / Operations / Supply Chain — ECO and supplier‑change impact, sustaining actions.
• Notified Bodies / Regulators / Auditors — defend compliance positions, support audits and investigations.
• Standards Committees / Industry Forums — monitor, interpret, and influence emerging requirements.

Education:

Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or related field (advanced degree preferred).

Exper…