POSITION SUMMARY:

The Senior Test Engineer plays a key role in overseeing the regulatory compliance testing and reporting for medical device products. This includes developing and executing test procedures for components, subsystems, and finished products. The role requires close collaboration with other engineers to ensure compliance activities are met. Additionally, the Senior Test Engineer will support lab management and assist with the development and improvement of lab operations.

KEY RESPONSIBILITIES:

• Lead complex projects, setting the technical direction, planning schedules, and coordinating detailed phases.
• Mentor and potentially train junior test engineers and technicians.
• Apply medical product safety standards (e.g., IEC 60601) to testing, ensuring compliance with national and international requirements, including collateral standards.
• Conduct testing such as leakage current and defibrillation proof in line with IEC 60601 series and related standards.
• Conduct thorough evaluations, testing, and reporting for medical devices to verify regulatory compliance.
• Familiarity with ISO 14971 Risk Management, IEC 60601-1-6, IEC 62366 Usability Engineering, and IEC 62304 Software Life Cycle processes.
• Assist with defining customer technical requirements, developing test strategies, and selecting equipment for proposals and quotes.
• Foster and maintain professional relationships with clients, offering consultations on complex technical matters.
• Coordinate with global labs to ensure consistent methods and accurate interpretation of results.
• Document testing outcomes, report corrective actions, and analyze data to determine expected results. Report deviations as necessary.
• Maintain confidentiality regarding client and company information.
• Perform other assigned duties as needed.

QUALIFICATIONS & REQUIREMENTS:

Knowledge, Skills, & Abilities:

• Collaborative team player with the ability to take direction.
• Advanced engineering knowledge with expertise in testing requirements, manufacturing processes, and applicable standards.
• Strong communication skills to present complex technical data clearly, both in writing and verbally.
• Advanced problem-solving, analytical, and troubleshooting abilities.
• In-depth understanding of international regulatory standards and approval processes.
• Knowledge of consumer expectations regarding product safety and usage.
• Ability to manage a dynamic workload with strong organizational and prioritization skills.
• Flexibility to travel when required (valid driver’s license needed).

Education:

• Bachelor’s degree in a technical discipline or equivalent experience in medical product safety testing.
• Regulatory testing training or certification.

Experience:

• At least 5 years of experience testing and evaluating medical devices according to regulatory standards.
• Familiarity with automated testing tools.
• Experience with testing standards such as NEC, NFPA, UL, CSA, IEC, and EN is preferred.