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Our mid-sized cardiovascular medical device client is seeking a permanent Principal Systems Test Engineer to join their team. This is a key technical leadership role responsible for leading the development and execution of comprehensive testing strategies. Responsible for evaluating, developing, and implementing test systems/tools/equipment, including design documentation. The position will provide Verification and Validation expertise to new product introduction of electro-mechanical, software-controlled medical devices. This role requires a deep understanding of medical device systems, strong leadership abilities, and a passion for ensuring product quality and compliance with regulatory standards.
Your role with the company:
- Lead the planning, design, and execution of system-level testing for medical devices, ensuring compliance with regulatory requirements (e.g., FDA, ISO), as well as customer and business needs.
- Develop and implement test plans, protocols, and procedures to verify and validate product functionality, performance, and reliability.
- Analyze and interpret test data, identify issues, and drive root cause analysis and resolution.
- Provide leadership and execution of best test method practices as part of a project team.
- Collaborate with cross-functional team members to ensure testing objectives and deliverables alignment.
- Design clean, easy-to-use test fixtures and user interfaces for test equipment that measure the robustness of design, provide error-checking, collect data, and give user feedback for acceptance and/or failure.
- Create and maintain traceability of test cases to requirements.
- Support regulatory submissions and audits by providing technical expertise and documentation.
- Use critical thinking and technical knowledge to solve complex system interaction problems.
Desired Profile:
- Bachelor’s degree in engineering, or other scientific discipline, preferably electrical, mechanical, software, biomedical systems, control engineering
- 8-10+years of experience in design verification
- Proven track record of leading and executing complex system-level tests for medical devices
- Experience in coordinating and working with external test labs
- Experience with electromechanical systems, sensors, control, and data acquisition systems development
- Proven background in automated test system development
- Strong analytical and problem-solving skills with the ability to troubleshoot complex system issues
- Experience creating test fixtures with Python and LabVIEW
- Ability to develop protocols, conduct system tests, and write reports
- Ability to select and use appropriate statistical techniques to design experiments and analyze data.
- Strong initiative, high energy, and passion for new technologies
Preferred:
- Proficient in programming languages such as C, Python, LabVIEW
- Project management experience and certification (e.g., PMP) is desirable
- Good understanding of production test equipment design issues such as user-friendliness, serviceability, and ruggedness and has implemented and transferred equipment to external suppliers for high-volume manufacturing
- Awareness and working knowledge of system-level constraints in all disciplines, including mechanical, electrical, human factors and software
- Knowledge of latest industry trends, emerging technologies, and regulatory changes to continuously improve testing methodologies
- Ability to travel up to 10%
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