Principal Systems Engineer – medical

Long-term contract opportunity 12-18 months
The Principal Systems Engineer will support the product engineering efforts for FDA regulated medical device technology. Support efforts spanning from creation of new systems, as well as manage ongoing projects within R&D. Work with cross functional engineering teams to define, design, and oversee the execution of projects related to medical systems and products.

Key Responsibilities:

  • Drive the progress of System Engineering within an FDA regulated environment, ensuring compliance with internal quality requirements and regulatory standards for Class I/II medical devices (FDA, ISO 14791, IEC 62304).
  • Evaluate design tradeoffs and balance technical risks while maintaining acceptable levels of risk throughout the product lifecycle.
  • Work with New Product Introduction (NPI) to incorporate Design for Excellence (DFx) and lean manufacturing concepts.
  • Collaborate with various teams to define engineering and system integration plans and acceptance criteria.
  • Lead technical product risk assessment activities, ensuring appropriate mitigations are identified and implemented.
  • Lead failure analysis and troubleshooting activities throughout the product lifecycle.


  • 6+ years experience in designing complex medical device systems in a regulated environment, with technical leadership experience preferred.
  • Knowledge of FDA, EU, IEC, AAMI, and ANSI standards related to medical devices is helpful.
  • Familiarity with optical products, fluid dynamics and heat transfer are a plus.
  • Bachelor’s degree in electrical, mechanical, biomedical, or systems engineering.
  • Experience creating Design History Files (DHF) and technical file deliverables.
  • Project management experience with standard tools and practices.

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