Location: Norwood MA
Duration: 12 Months + Potential to convert fulltime
Demonstrates proficiency in performing root cause analysis and initiating and leading troubleshooting activities. This person leads activities related to failure mode and error analysis of a next generation type II medical device.
Leads the development of test plans and data acquisition in support of ongoing product development as well as informal (dry run) and formal (design V&V) testing of complex electro-mechanical, software-driven medical devices; responsibilities may include managing systems HW& SW integration, software loads and updates, configuration control, and test execution and reporting.
Works with subsystem teams, domain subject matter experts, and suppliers in the identification, logging, assessment, and resolution of integration and test issues.
Specify, design, and develop test systems (hardware & software); ensure that all test systems and equipment are appropriately validated and controlled
Collaborates with a diverse technical team to create, update, and maintain documentation that is or will become part of the product design history file (DHF) for a medical instrument.
Work closely with all engineering disciplines, including Systems, Electrical, Mechanical, Disposables, and Software Engineering, as well as Project Management and Quality personnel, to verify and validate product designs.
Applies knowledge of regulations and standards including: FDA design controls, ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
Perform design reviews, FMEAs, risk / hazard analysis, establish technical requirements