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.

Education

• Bachelor’s or higher degree in engineering, biological sciences or related field.

Experience

• 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.

Job Type: Full-time

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