Senior Medical Device R&D Project Manager

R&D Partners; Thousand Oaks (CA); On-site; USD 160,000 - 180,000; Full time

Job summary

R&D Partners in Thousand Oaks, CA seeks an experienced Project Manager to lead end-to-end medical device development programs. You will coordinate R&D, Engineering, Regulatory Affairs, Quality, and Manufacturing teams, drive plans and budgets, and ensure compliance with ISO 13485, FDA 21 CFR Part 820 and Design Controls.

This role requires strong stakeholder management, excellent communication, and the ability to navigate complex product development environments while delivering on cost,

Qualifications

• Bachelor's degree in Engineering or related technical discipline required.
• 7+ years of project management experience in medical device industry.
• Experience managing product development or R&D projects through full design lifecycle.

Responsibilities

• Lead end-to-end medical device R&D projects.
• Develop and maintain detailed project plans, schedules, budgets, resource allocations, and risk registers.
• Coordinate activities across R&D, Engineering, Quality Assurance, Regulatory Affairs, Clinical Affairs, Manufacturing, Marketing, and external partners.
• Ensure design and development activities comply with quality and regulatory requirements (Design Controls, Risk Management).
• Monitor progress, identify risks, and implement mitigation plans to meet objectives.
• Facilitate project governance reviews and report to senior leadership and stakeholders.
• Manage external suppliers, consultants and development partners.
• Drive cross-functional collaboration to complete technical deliverables and milestones.
• Support preparation of technical documentation and development records.
• Ensure projects meet cost, quality, timeline and performance objectives.
• Champion continuous improvement in product development and project management processes.

Skills

Project management

Cross-functional leadership

Regulatory compliance

Stakeholder management

Communication

Education

Bachelor's degree in Engineering

Job description

R&D Partners in Thousand Oaks, CA seeks an experienced Project Manager to lead end-to-end medical device development programs. You will coordinate R&D, Engineering, Regulatory Affairs, Quality, and Manufacturing teams, drive plans and budgets, and ensure compliance with ISO 13485, FDA 21 CFR Part 820 and Design Controls.

This role requires strong stakeholder management, excellent communication, and the ability to navigate complex product development environments while delivering on cost,