Senior MDR Project Lead — Medical Devices & Supply Chain

Insight Global (United States); Lafayette (CO); On-site; USD 120,000 - 160,000; Full time

Job summary

Insight Global is seeking a Principal Project Management Specialist for a top medical device client in Colorado. You will lead complex, cross-functional MDR implementation and released-product changes, coordinating with Engineering, Quality, Regulatory Affairs, Manufacturing, and Supply Chain to deliver executable plans.

You will own schedules, risks, milestones, and escalations, influence external partners, and ensure readiness and continuity of supply while partnering with OEMs, contract

Qualifications

• Bachelor’s degree with 7+ years in PM or an advanced degree with 5+ years.
• Proven PM leadership on complex cross-functional projects.
• Extensive supplier/OEM and contract manufacturer experience.
• Experience with MDR/Regulatory remediation and design changes.
• Strong communication and stakeholder-management skills.

Responsibilities

• Lead complex MDR implementation and released-product changes from initiation to completion.
• Coordinate across Engineering, Quality, Regulatory, Manufacturing, Ops, and Supply Chain.
• Work with OEMs and suppliers to define requirements, deliverables, and timelines.
• Drive schedules, budgets, risks, dependencies, and governance.
• Lead cross-functional meetings and executive-level project updates.
• Influence partners without direct authority to meet milestones.

Skills

Cross-functional

PM expertise

Supplier/OEM management

Regulatory MDR experience

Stakeholder management

PMP certification

Lean Six Sigma

Influence without authority

Medical device quality systems

Engineering/Operations background

Education

Bachelor's degree

MBA or MS

Job description

Insight Global is seeking a Principal Project Management Specialist for a top medical device client in Colorado. You will lead complex, cross-functional MDR implementation and released-product changes, coordinating with Engineering, Quality, Regulatory Affairs, Manufacturing, and Supply Chain to deliver executable plans.

You will own schedules, risks, milestones, and escalations, influence external partners, and ensure readiness and continuity of supply while partnering with OEMs, contract