Senior Project Engineer - EMC, Product Safety and Environmental Testing
Listed on 2026-10-11
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Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist -
Engineering
Quality Engineering, Regulatory Compliance Specialist
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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.
- 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.
- Bachelors degree in…
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