Senior Project Program Manager

Convergent dental is looking for a skilled and experienced Sr Project Program Manager to assist with the deployment and growth of its Solea laser ablation system used for oral procedures. This position will report directly to the VP of Research & Development & Engineering and will have direct accountability for program and project initiatives across the entire Solea product portfolio. The ideal candidate has worked in the medical device arena in a regulated environment. We are looking for a naturally collaborative team member who is comfortable across multiple cross-functional areas and has a solid understanding of how to navigate rapid change and quick-to-market activities.

About the Role

Primary Responsibilities:

• Coordinate internal cross-functional teams and lead end-to-end product development from concept, design, development, FDA clearance, and launch.
• Ensure projects are delivered on-time, within scope, and within budget.
• Assist in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility.
• Ensure resource availability and allocation.
• Develop detailed project plan(s) to monitor and track progress and reporting to Senior Leadership.
• Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques.
• Measure project performance using appropriate tools and techniques.
• Perform program risk management to minimize/expose potential risks to business and product adoption.
• Establish and maintain relationships with third parties/vendors.
• Create and maintain comprehensive project documentation including Design History File and deliverables for the design control process.

Qualifications:

• BS degree in Engineering or related technical discipline, advanced degree would be preferred; PMP a plus.
• 5 years of Engineering Project Management experience preferably in medical devices, product development, and/or process development.
• 5 years of Project Management experience in medical devices.
• Solid technical experience with a proven track record of managing the development and commercialization of medical devices within a regulated environment.
• Strong understanding of product development and ongoing manufacturing operations including process development, mfg. engineering, supply chain, sourcing, and production.
• Experience in managing and working in a multidisciplinary team.
• Knowledge of quality and regulatory requirements guiding medical device development, plus experience dealing with regulatory agencies or outside professional groups (e.g., FDA, EU MDR, ISO).
• Strategic long term & short term thinking, ability to multitask with a sense of urgency.
• Knowledge of Confluence, Jira, and requirements tracing software (JAMA).
• Computer skills (especially MS Office, MS Project, and Outlook).

Key Skills:

• Strong understanding of product development and ongoing manufacturing operations including process development, mfg. engineering, supply chain, sourcing, and production.
• Experience in managing and working in a multidisciplinary team.
• Knowledge of quality and regulatory requirements guiding medical device development, plus experience dealing with regulatory agencies or outside professional groups (e.g., FDA, EU MDR, ISO).
• Strategic long term & short term thinking, ability to multitask with a sense of urgency.
• Computer skills (especially MS Office, MS Project, and Outlook).