Senior Project Engineer - EMC, Product Safety and Environmental Testing

Siemens Healthineers

14d•$98,140 - $134,937•Onsite

About The Position

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.

Requirements

Bachelors degree in Engineering, a related technical field or an equivalent combination of education and relevant experience.
Minimum of 5 years of engineering, compliance, test, project or product-development experience; regulated industry experience preferred.
Working knowledge of applicable EMC, product safety, environmental, or certification standards, including the IEC 61326, IEC 61010, or IEC 60601 series.
Demonstrated experience with project planning, technical documentation, scheduling, and stakeholder coordination.
Strong written, verbal, organizational, analytical, and problem-solving skills.
Proficiency in Microsoft Office applications and the ability to learn laboratory document and record-management systems.

Nice To Haves

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.

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 escalate risks to scope, quality, schedule, cost, or safety.
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.