Principal Compliance Engineer - EMI/EMC/Electrical Safety

Overview

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.

Qualifications

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

Skills & Capabilities

• Recognized expert-level knowledge of EMI/EMC and electrical safety principles, test methods, 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, deviations, 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.