Overview

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.

Responsibilities

Key Accountabilities

• 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.

Networking/Key relationships

• R&D Engineering - design-in requirements, align test plans, resolve tradeoffs; complex.
• Regulatory Affairs & Quality - submissions, audit defense, risk-based rationale; high-stakes decision partnership.
• Manufacturing / Operations / Supply Chain - ECO and supplier-change impact, sustaining actions.
• External Test Labs - test strategy, deviation resolution, retest scope definition.
• Notified Bodies / Regulators / Auditors - defend compliance positions, support audits and investigations.
• Standards Committees / Industry Forums - monitor, interpret, and influence emerging requirements.

Qualifications

Minimum Knowledge & Experience for the position:

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.

Preferred Qualifications:

• 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.

Skills & Capabilities:

• 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.

Travel requirements:

• < 20% travel may be required

The annual base salary range for this role is currently $160,000.00 range to $200,000.00. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.