JOB SUMMARY 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. RESPONSIBILITIES
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.