Systems Engineer
An exciting opportunity exists for a candidate to be part of the development of innovative medical diagnostic instrumentation. The qualified candidate will be part of our growing world-class System Development team.
Overview of Responsibilities:
The qualified candidate will lead and execute System Engineering and Quality Assurance tasks, helping design, test, and manufacture a family of innovative, benchtop and portable in-vitro medical devices. The day to day activities will include, but will not be limited to: overview Quality Assurance, implement and track T2 Biosystems’ Quality System, prepare technical reports, and participate in interdisciplinary technical and organizational discussions. The candidate will be expected to work closely with T2 Biosystems’ technical team, overview OEM vendor’s compliance and to coordinate efforts with regulatory experts to successfully attain FDA approvals.
Job Requirements:
• Masters in System, Mechanical or Electrical Engineering, Physics, or Chemistry
• Seven years of experience developing and commercializing instrumentation, with established track record of leadership in product introduction projects
• Leadership during FDA approval processes
• Demonstrated experience in implementing and tracking Quality Systems, with specific knowledge of IEC 60601-1 and ISO 13485 standards
• Creative problem solver, fast learner, and effective communicator
• Effective at working in a cross-disciplinary and dynamic environment.
Highly Desirable Skills:
• Project management experience
• Expertise in magnetic resonance instrumentation and methods.