We have an immediate need for an experienced hands-on Product Test Engineer with broad experience to establish and execute test capabilities for advanced catheter-based medical sensors and measurement systems incorporating electronics, software and photonics technologies.
You will be working closely with cross-functional product engineering teams of QA, reliability, mechanical, chemical, photonics, software, hardware and electrical engineers to define, develop, and execute company’s test strategy. Validate test systems to make our innovative products a clinical and market success.
- Strong background in design of in-line and final test, with experience in developing methodologies and test systems for sensors, photonics components, board-level sub-systems and systems. Experienced in developing requirements and specifications, sourcing hardware, and data analysis and reporting.
- PhD or MSc in EE or engineering and 7+ years of experience, ideally in medical electronics product testing with significant photonics, software, embedded and hardware component. Experience in testing of catheter-based medical products is a plus.
- Working knowledge and use of regulatory requirements as applicable to medical products with electronic content, such as IEC 60601 (safety and effectiveness), ISO 14971 (application of risk management to medical devices), and ISO 13485 (QMS).
- Track record of identifying and executing complex engineering projects.
- Experience developing automated and manual tests and test plans at unit, integration and system test levels, and performing in-line, final and reliability testing, design verification and validation activities, including associated documentation, reporting and records.
- Experienced in establishing and maintaining effective relationships with external companies, suppliers, and vendors to optimize product development, including design changes, performance improvements, validation activity, and risk analysis. This will include responsibility for developing and executing the project schedule to ensure timelines are met.
- Ability to support R&D and Quality teams by building quality into all aspects of work and by maintaining compliance with company operating procedures and applicable regulatory standards.
- Experienced in formulating and implementing hardware and reliability metrics to monitor quality and compliance and facilitate ISO 13485 certification.
- Excellent people skills and ability to communicate well in English, both written and spoken.
Candidate must have a desire to work in a results-oriented culture that fosters team spirit, innovation, and a can-do attitude. It is also necessary to have the ability to work independently, in a team setting, and perform multiple simultaneous substantial projects.
The position is full-time and permanent. Salaries are competitive.
Women are encouraged to apply.