Project Manager

Project Manager – Medical Devices

Location: Plano, TX (On-site)

Compensation: Up to $150,000 + bonus + comprehensive package

Are you a technically driven Project Manager with a strong engineering foundation and a track record of delivering medical device projects from concept through to commercial launch? We’re partnered with a leading medical device manufacturer experiencing continued growth and investment across their product portfolio.

The Role

As Project Manager, you will take ownership of complex, cross-functional projects spanning new product development, sustaining engineering, product improvements, and design changes. You’ll be responsible for creating detailed project plans, defining milestones, managing risks, and driving execution through collaboration with Engineering, Quality, Regulatory Affairs, Manufacturing, Supply Chain, and Marketing.

You will:

• Lead full design lifecycle execution from requirements definition, prototyping, DV/V testing, and verification/validation through to commercialization
• Coordinate and chair project meetings, drive accountability, and communicate progress to leadership
• Manage engineering change activities, component obsolescence, supplier modifications, and packaging/labeling updates
• Ensure project documentation and DHF compliance under FDA 21 CFR 820, ISO 13485, MDD/MDR, and internal QMS requirements
• Identify and mitigate risks using structured tools such as FMEA and hazard analysis (ISO 14971)
• Support CAPA-related initiatives and continuous improvement strategies
• Work closely with external vendors, contract manufacturers, and sterilization providers
• Prepare high-quality documentation, reports, and cross-functional project deliverables

You Will Bring

• Degree in Mechanical, Biomedical, or related engineering discipline
• Hands-on engineering experience within medical devices prior to moving into project management
• Proven track record of managing development and commercialization projects in a regulated environment
• Deep understanding of design controls, verification/validation, risk management, and documentation requirements
• Strong ability to influence cross-functional teams without direct supervisory authority
• Excellent communication, stakeholder management, and technical decision-making skills
• Demonstrated success balancing cost, timeline, quality, and regulatory considerations

Why Join?

• Impact products that directly improve patient safety and clinical outcomes
• Work in an innovative, highly collaborative culture with exposure across the business
• Opportunities for career advancement as the organization continues to scale
• Competitive salary, strong benefits, and long-term career stability

If you’re an engineer-turned-project-manager who thrives in a regulated, fast-moving environment — we’d love to speak with you.