MDR Compliance Project Lead – Engineering

Primary Talent Partners, LLC; Lafayette (CO); On-site; USD 83,000 - 96,000; Full time

Benefits offered by this job

Supplemental benefits package

Job summary

Primary Talent Partners is seeking a Project Manager (Engineering) for a 14-month contract in Lafayette, CO. You will lead MDR implementation and compliance change-control projects across Regulatory Affairs, Quality, Engineering, and Manufacturing to ensure released products meet EU MDR and provide ongoing supply continuity.

The role requires a Bachelor's degree and 7+ years of relevant experience (or an advanced degree with 5+ years) and experience coordinating cross-functional teams, managing

Qualifications

• Bachelor's degree and a minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years.
• Demonstrated experience leading complex cross-functional projects in medical devices or regulated products.
• Strong ability to translate regulatory, quality, and technical requirements into executable plans.
• Experience coordinating with OEMs, contract manufacturers, or external suppliers.
• Experience managing schedules, budgets, risks, governance, and executive communications.

Responsibilities

• Lead MDR implementation and compliance change-control projects for released products from initiation to closure.
• Guide cross-functional teams to align execution with compliance and business objectives.
• Develop integrated plans linking technical deliverables with regulatory and quality requirements.
• Coordinate MDR transition planning with OEMs and suppliers.
• Manage scope, schedules, budgets, risks, and governance; provide data-driven updates to leadership.

Skills

PMP

Lean

Six Sigma

Stakeholder mgmt

Regulatory compliance

Education

Bachelor's degree

Advanced degree

Job description

Primary Talent Partners is seeking a Project Manager (Engineering) for a 14-month contract in Lafayette, CO. You will lead MDR implementation and compliance change-control projects across Regulatory Affairs, Quality, Engineering, and Manufacturing to ensure released products meet EU MDR and provide ongoing supply continuity.

The role requires a Bachelor's degree and 7+ years of relevant experience (or an advanced degree with 5+ years) and experience coordinating cross-functional teams, managing