The R&D Project Manager is responsible for planning and executing the portfolio of Novidan new product development projects. S/He will deliver hardware and software medical device projects in alignment with the Stage Gate process and in compliance with FDA regulations and ISO guidance. The project manager must be highly organized with an attention for detail, but still able to make quick progress. S/He will communicate effectively with all stakeholders within Novidan and with key customers to enable the team to meet business and technical objectives.
- Owns the Stage Gate process from Alpha to transfer to production and close.
- Create project management deliverables eg. timelines, gantt charts, burndown charts, project boards, design review minutes, risk management reports, etc.
- Maintain project management tools and ensure accurate reporting within, eg. Sharepoint sites, Trello, Jira, gantt charts, and time tracking spreadsheets.
- Ensure project activities and documentation are properly planned, prioritized and executed to meet all relevant FDA design controls and ISO guidelines.
- Communicate clearly and timely with Executives, R&D staff, Operations and customers.
- Ensures adherence of team members deliverables to Novidan policies, FDA regulations and ISO guidelines.
- Coordinate with Operations and suppliers for prototypes and development builds.
- Coordinate and lead efficient meetings with clear objectives to capture project progress, identify and manage issues and risks, facilitate decision making and communicate high priority subjects.
- Contribute to process improvement within project management and R&D.
Education and Certification(s) Required
Bachelor’s Degree with 2+ years experience in product development required
PMI certification desired
- Experience in product development for 2+ years required
- Experience with structured development process with rigorous documentation required
- Experience in medical device product development highly desired
- Experience with FDA design controls and regulated work environments highly desired
- Intermediate knowledge of project management tools and best practices required
- Intermediate knowledge of waterfall and agile scrum methodologies required
- Intermediate knowledge of FDA 21CFR820 and ISO 13485 desired
- Intermediate knowledge of FDA design controls desired
Skills / Abilities Required
- Ability to manage challenges and proactively drive risk mitigation strategies
- Advanced communication skills both verbal and written
- Advanced skill in MS Office tools
- Intermediate negotiation and conflict management skills
- Intermediate skill in project management tools eg. Sharepoint, Trello, Jira, MS Project
Working Environment & Culture
Normal office and laboratory conditions. Mobile work flexibility available.
Some company financial, supplier pricing, intellectual property and trade secrets.
Less than 10%. Some US or international travel may be required.