EMC & Product Safety Project Lead: Testing & Compliance

Siemens Healthineers AG; United States; Sur place; USD 98 000 - 135 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long‑term & short‑term disability

Paid parking/public transportation

Paid time off

Résumé du poste

Siemens Healthineers is seeking a Compliance Project Engineer to plan, coordinate, and deliver compliance testing projects from intake to final report in a regulated laboratory environment.

You will define test scope, manage STL contracts, and ensure approvals, while coordinating with product development teams and certification bodies. This role requires hands‑on testing, risk management, and strong documentation skills.

Qualifications

• 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.

Responsabilités

• Plan and coordinate EMC, product safety, and environmental testing projects.
• Define test scope, inputs, articles, configurations, standards, acceptance criteria, schedules, and deliverables.
• Prepare test plans and STL test contracts with required approvals.
• Issue test reports and data packages and coordinate reviews for design verification deliverables.
• Track deviations and contract changes with justification and approvals.
• Coordinate laboratory capacity, personnel, equipment, facilities, and external resources; escalate risks.
• Monitor test execution, open issues, changes, retesting, corrective actions, and decisions.
• Ensure plans, reports, approvals, and records are complete and stored correctly.
• Interpret standards and coordinate with CBTL and certification bodies for clarification.
• Support audit readiness and responses with accurate records and evidence.
• Provide timely project updates to stakeholders and leadership.
• Participate in cross-training and knowledge transfer from experienced staff.
• Assist hands‑on testing or report preparation when needed and competent.
• Take on additional lab and project duties as assigned.

Connaissances

In‑vitro diagnostics knowledge

Compliance project coordination

ISO/IEC 17025 familiarity

EMC/product safety/environmental test

Risk management & CAPA

Cross-functional influence

Formation

Bachelor's degree in Engineering

Outils

Microsoft Office

Description du poste

Siemens Healthineers is seeking a Compliance Project Engineer to plan, coordinate, and deliver compliance testing projects from intake to final report in a regulated laboratory environment.

You will define test scope, manage STL contracts, and ensure approvals, while coordinating with product development teams and certification bodies. This role requires hands‑on testing, risk management, and strong documentation skills.