Product Development Project Manager

Responsibilities:

• Lead cross-functional teams through medical device product development, sustaining, remediation, and commercialization projects.
• Develop and manage project plans, timelines, milestones, resources, risks, and deliverables.
• Partner with R&D, Engineering, Quality, Regulatory, Manufacturing, and Supply Chain teams.
• Drive projects through phase-gate processes while ensuring on-time and compliant execution.
• Identify and mitigate project risks, resolve technical/business issues, and remove project roadblocks.
• Support product requirements, design changes, risk management, FDA submissions, and commercialization activities.
• Communicate project status, risks, and key decisions to stakeholders and senior leadership.
• Promote continuous improvement and ensure successful delivery of project objectives.

Required Qualifications:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science & Engineering, or a closely related engineering discipline.
• Minimum 3 years of project management experience.
• Minimum 5 years of relevant experience in product development and product design.
• 2–4 years of product development/design experience within the medical device industry, preferably with Class II medical devices.
• Proven experience leading cross-functional teams and managing multiple project workstreams.
• Experience managing sustaining, remediation, or product lifecycle projects.
• Experience with project planning, risk management, integrated project schedules, resource planning, and phase-gate product development processes.
• Experience with medical device regulations, FDA requirements, and design controls.
• Demonstrated success in commercializing new products and/or remediating products already in the market.
• Strong communication, stakeholder management, negotiation, problem-solving, and leadership skills.
• PMP certification.