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Project/Product Manager

San Jose, CA
The Project/Product Manager will lead the successful and timely releases of our next generation medical device SW and/or HW. Will help define product requirements and set-up engineering, clinical and regulatory schedules. Will give regular updates to the team and senior management as to project progress. Will identify risks and help implement mitigations. We are looking for a Project/Product Manager who has experience with managing the product development cycles of medical devices including conceptualization, design and development, verification and validation, manufacturing, regulatory affairs, and commercialization. We work as a tightly knit team in a fast paced environment surrounded by innovative technology. If you feel this is a good fit, we'd love to hear from you.
  • Manage projects to ensure the successful and timely release of our next generation medical device SW and/or HW.
  • Define product roadmap and requirements for our next generation medical device SW and/or HW.
  • Work with cross-functional teams such as algorithms, manufacturing, mechanical engineering, firmware, hardware, software, cloud, regulatory, quality, sales, and marketing.
  • Document and contribute in the requirements development
  • Track project, highlight critical path, escalate issues to senior management, prioritize tasks, and evaluate tradeoffs to keep projects on schedule.
  • Lead risk management efforts to identify root causes and develop mitigation strategies.
  • Communicate regular updates about progress and issues to team and senior management.
  • Follow medical device development SOPs.
  • Work with internal company teams and external consultants and vendors.
  • Project a “Let’s get it done!” attitude.
  • Bachelor’s or higher degree in engineering, biological sciences or related field.

  • Minimum 3 years experience in project/product management of medical devices.
  • Experience in creating documentation for requirements, work instructions etc.
  • Both hardware and software medical device experience is preferred.
  • Experience conducting project management in FDA regulated environment.
  • Experience preparing a product for a 510(k) FDA submission and commercialization.
  • Experience with design controls and documentation.
  • Experience with project management tools to create Gantt charts (e.g. SmartSheets).
  • Experience with scoping out timelines and budgets.
Knowledge and Training
  • Collaborative, respectful of all teammates, and accountable.
  • Excellent oral and written communication skills.
  • Ability to clearly present project status and any risks/issues to team and senior management.
  • Champion projects that you are leading and help motivate team to stay on track.
  • Proven track record for managing products from conceptualization, to design and development, to verification and validation testing, to transfer to manufacturing.
  • Ability to understand the critical path/resource of the projects  
  • Ability to anticipate potential future risks and help implement early mitigation.
  • Good negotiator and capability to identify tradeoffs between scope, resources and timelines.
  • Detail oriented and self-motivated.
  • Comfortable with working in a dynamic and agile work place.
  • Certified in project management (PMP, CSM) is a plus.

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