Principal Compliance Engineer - EMI/EMC

Job Information
Number
ICIMS-2026-10434
Job function
R&D
Job type
Full-time
Location
Werfen - Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States
Country
United States
Shift
1st
About the Position

Introduction

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.

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... For full info follow application link.

Werfen is an Equal Employment Opportunity company, committed to selecting, promoting, and compensating individuals regardless of race, religion, sex, age, national origin, or qualifiable disability.