Project Manager (R&D)

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

Ready to lead cutting-edge medical device innovations while working with world-class cross-functional teams?

R&D Partners is seeking an experienced Project Manager to lead cross-functional medical device development projects. This role involves driving R&D programs, coordinating multidisciplinary teams, managing project timelines and budgets, and ensuring compliance with regulatory and quality requirements.

This is a highly visible position requiring strong stakeholder management skills, technical expertise in medical device development, and the ability to navigate complex product development environments.

Applicants must have legal authorization to work in the United States.

Responsibilities

• Lead end-to-end medical device R&D projects.
• Develop and maintain detailed project plans, schedules, budgets, resource allocation plans, and risk registers.
• Coordinate activities across multidisciplinary teams, including R&D, Engineering, Quality Assurance, Regulatory Affairs, Clinical Affairs, Manufacturing, Marketing, and external partners.
• Ensure design and development activities comply with applicable quality and regulatory requirements, including Design Controls and Risk Management processes.
• Monitor project progress, identify risks and issues, and implement mitigation plans to meet project objectives.
• Facilitate project governance reviews and provide regular updates to senior leadership and key stakeholders.
• Manage external suppliers, consultants, and development partners supporting project execution.
• Drive cross-functional collaboration to ensure timely completion of technical deliverables and project milestones.
• Support preparation of technical documentation, design history files, and development records.
• Ensure projects meet cost, quality, timeline, and performance objectives.
• Champion continuous improvement initiatives within product development and project management processes.

Key Skills and Requirements

Required Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or a related technical discipline.
• 7+ years of project management experience within the medical device industry.
• Proven experience managing product development or R&D projects through the full design lifecycle.
• Strong understanding of medical device development processes and stage-gate methodologies.
• Experience working within regulated environments governed by: ISO 13485 , ISO 14971, FDA 21 CFR Part 820
• Demonstrated success managing cross-functional technical teams.
• Excellent communication, leadership, organizational, and stakeholder management skills.

Preferred Qualifications

• PMP, PRINCE2, Agile PM, or equivalent project management certification.
• Experience working with outsourced design and manufacturing partners.
• Exposure to clinical evaluation and regulatory submissions.
• Strong leadership and team coordination skills.
• Strategic planning and execution.
• Risk management and problem-solving.
• Budget and resource management.
• Influencing and stakeholder engagement.
• Decision-making in complex technical environments.
• Ability to thrive in a fast-paced, innovation-driven setting.

Compensation

• $160 000.00 - $180 000.00/Annum

For more information, please contact Toby Shelton.