Senior Project Engineer - EMC, Product Safety and Environmental Testing

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 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.

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 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.

Work Environment and Expectations

Full-time, onsite role located in Newark, Delaware. The position operates in a hands-on laboratory and product-development environment and may require occasional overtime, domestic travel, manual handling of equipment or test articles, and collaboration with global teams.