This is an R&D engineering position with an emphasis on design and testing of embedded software, mechanical, and electrical designs into electromechanical medical devices. The individual will work with a multidisciplinary team of scientists to design construct, and execute engineering, formal verification, and reliability tests. The individual will lead prototype builds, collect and analyze data, and author associated technical documentation.
- Work with multidisciplinary R&D team members to design, construct, author, and execute engineering, verification, and reliability tests and protocols
- Collect and analyze data, and generate reports
- Support development of project documentation (dFMEAs, specifications, plans)
- Participate in technical reviews
- Lead development of fixtures and associated scripting/automation for test efforts
- Maintain configuration management documentation and support instrument prototype builds
- Lead instrument, PCB, and firmware troubleshooting and issue resolution
- Lead design control guidelines and Quality requirements within the company’s regulated ISO environment
- Install, maintain, verify performance and repair equipment from multiple manufacturers at customer sites ensuring best-in-class service within established time frame.
- BS in Engineering or related field, or equivalent experience, plus 3+ years of relevant work experience. Biomedical Engineering preferred
- Preferred 2 or more years work experience designing and testing electro-mechanical systems, equipment and components for the medical device or diagnostics industry
- Well-grounded in fundamental engineering design principles and test methods with demonstrated hands-on design competency working with complex medical instrumentation
- Experience with complex laboratory or engineering test equipment, data acquisition systems, engineering design documentation, and calibration procedures
- Basic understanding in programming techniques (C/C++/Python) and/or script writing (using Labview, Arduino, PLCs, or similar)
- Strong troubleshooting skills
- Strong technical writing and communication skills.
- Knowledge of FDA QSR, specifically design controls
- Experience in microfluidic device development for analytical or diagnostics applications.