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Senior Project Engineer - EMC, Product Safety and Environmental Testing

Job in Newark, Essex County, New Jersey, 07175, USA
Listing for: Siemens Healthineers AG
Full Time position
Listed on 2026-10-11
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
  • Engineering
    Quality Engineering, Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 98000 - 134000 USD Yearly USD 98000.00 134000.00 YEAR
Job Description & How to Apply Below

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

The Compliance Project Engineer plans, coordinates, and delivers compliance testing projects from intake through final report issuance. This role is the primary interface between product-development teams and the laboratory, and is responsible for test scope definition, test contracts, scheduling, standards interpretation, documentation, approvals, and project deliverables in an accredited, regulated environment.

Key Responsibilities
  • Plan and coordinate assigned EMC, product safety, and environmental testing projects in accordance with laboratory procedures, testing strategies, project commitments, and applicable standards.
  • Work with customers and engineering teams to define test scope, required inputs, test articles, configurations, applicable standards, acceptance criteria, schedules, and deliverables.
  • Prepare and maintain test plans and STL test contracts, and coordinate the required customer, technical, and quality approvals.
  • Issue test reports and data packages, and coordinate subject‑matter expert and quality review and approval for design verification deliverables.
  • Evaluate deviations from an STL test contract and determine, with laboratory management, whether a contract revision or a new contract is required, ensuring the basis for the decision is documented.
  • Coordinate laboratory capacity, personnel, equipment, facilities, and external resources, and escal ...
  • Track test execution, open issues, configuration changes, failures, retesting, corrective actions, and decisions through project completion.
  • Ensure test plans, reports, approvals, and supporting records are complete, traceable, controlled, and stored in the required systems and repositories.
  • Interpret applicable standards and coordinate with technical experts, CBTL, and national certification bodies when requirements, scope, or conclusions require clarification.
  • Support audit readiness and audit responses by providing accurate project records, technical evidence, status, and corrective‑action information.
  • Communicate clear and timely project updates to internal stakeholders and leadership, including risks, resource conflicts, schedule changes, and decisions required.
  • Participate in cross‑training and structured knowledge transfer, including capture of standards expertise and lessons learned from experienced laboratory personnel.
  • Support hands‑on testing, technical troubleshooting, or report preparation when needed and within demonstrated competency.
  • Perform additional laboratory and project responsibilities as assigned by the Senior Manager based on demonstrated competency, workload, and organizational needs.
Desired Skills for Success in this role
  • Experience operating and maintaining in‑vitro diagnostic products.
  • Experience coordinating compliance, certification, verification, or product‑development projects in a regulated environment.
  • Familiarity with ISO/IEC 17025, IECEE CTF programs, quality systems, audit preparation, and controlled technical records.
  • Working knowledge of EMC, product safety, and environmental testing standards used for medical or in‑vitro diagnostic equipment.
  • Experience with risk management, configuration control, corrective actions, and formal technical communication.
  • Ability to influence cross‑functional teams, resolve ambiguity, and maintain momentum across competing priorities.
Required skills for the success in this role
  • Bachelors degree in…
Position Requirements
10+ Years work experience
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