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The Lead Product Engineer’s role is to lead product development, productionization and deployment of software as a medical device.


  • Responsibility for product development activities, including design, implementation, testing and deployment to meet the Company’s quality, reliability and compliance requirements
  • Deliver the highest quality products, with supporting tools and processes
  • Establish and manage process improvement activities
  • Drive clarity and consistency in documentation
  • Follow and teach best practices for coding
  • Provide proactive technical guidance to the Development Team fostering the concepts of re-use, design for scale, stability, operational efficiency of solutions, and a learning culture
  • Investigate, evaluate, and recommend technologies, tools, and frameworks that contribute to accelerating delivery of the product roadmap
  • Devise and implement proof-of-concept (POC) activities to guide technology decisions when appropriate
  • Balance upfront planning and encourage emerging designs while executing initiatives in an Agile environment



  • Bachelor’s in Engineering or Science
  • 10+ years of medical device software engineering
  • 5+ years leading software product development
  • Experience with the 510(k) regulatory pathway for product clearance as well as deployment and monitoring of FDA regulated software
  • Extensive experience with Git, Python and Cloud Computing (preferably AWS or GCP)
  • Experience with Agile/scrum methodologies
  • Strong verbal and written English communication skills with an ability to effectively communicate plans and recommendations at multiple levels in the organization
  • Strong attention to detail and track record of meeting deadlines
  • Ability to work in an entrepreneurial setting and be hands-on when needed
  • Ability to lead a team towards goals and bring clarity to the team on those goals


  • Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304
  • Familiarity with various Software Development Lifecycles (SDLC)
  • Ability to author technical reports, business correspondence and standard operating procedures
  • Experience participating in regulatory audits and inspections

Contact Us for More Information

We're always looking for talented, motivated individuals to join our team - get in touch!


Contact Us About This Position

We're always looking for talented, motivated individuals to join our team - get in touch!