Sr. Systems Engineer
Health Recruiters International
Andover, Massachusetts, United States
Job type: fulltime
Job industry: I.T. & Communications
Our Client is an industry leading Medical Device Company that is rapidly growing and has won many recent "Work Place" awards.
Lead systems engineering efforts for a complex, software-driven medical device
Lead Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed.
Perform Risk Analyses, including Fault Tree Analysis (FTA), Operator Misuse Analysis (OMA), and Failure Mode and Effects Analysis (FMEA) activities.
Work with subsystem teams, domain subject matter experts, and suppliers in the identification,
Respond rapidly and flexibly to emerging issues in production, quality, engineering, or supply chain.
Create and review process, design, and fixture documentation including work guidelines, specifications, and CAD models / drawings.
BS in Systems Engineering, Biomedical Engineering, Electrical Engineering, Computer Science, or Mechanical Engineering (or equivalent in a technical/scientific field); MS preferred.
Experience working as a Systems Engineer on product design, development, and/or testing; experience with class II medical device products is preferred.
Strong understanding of medical device product design and regulatory processes.
Experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, and ISO 14971.
Strong understanding of system design, electronics, mechanical and software integration.