Prin PD Project Mgmt Spec

Primary Talent Partners has a new contract opening for a Project Manager (Engineering) with our medical device client in Lafayette, CO. This is a 14-month contract with a potential for extension.

Pay: $60.00 - $70.00/hr
; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.

Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

Schedule: Day Shift - M-F, 9am-5pm

Description: Careers that Change Lives As a Principal Project Management Specialist within the Compliance PMO, you will lead complex EU Medical Device Regulation (MDR) implementation and compliance change-control projects for released products. You will align Regulatory Affairs, Quality, Engineering, Operations, Supply Chain, manufacturing sites, original equipment manufacturers (OEMs), contract manufacturers, and external suppliers to translate compliance requirements into executable plans.

Your work will protect compliant product availability and continuity of supply while strengthening released-product implementation, operational readiness, risk management, and change execution. This role is ideal for an experienced project leader who combines disciplined program management, operational judgment, and influence across internal and external organizations.

• Lead multiple complex MDR implementation and compliance change-control projects for released products from project initiation through closure.
• Guide cross-functional teams across Regulatory Affairs, Quality, Engineering, Manufacturing, Operations, Supply Chain Planning, Supplier Quality, and other partners to align execution with compliance and business objectives.
• Develop integrated plans connecting technical deliverables, regulatory and quality requirements, supplier activities, operational constraints
• Collaborate with OEMs for MDR Transition planning by establishing deliverables, milestones, decision rights, escalation paths, recovery actions, and readiness expectations.
• Coordinate released-product changes across components, suppliers, manufacturing processes, specifications, packaging, labeling, quality systems, and regulatory requirements.
• Manage scope, schedules, budgets, resources, risks, assumptions, dependencies, decisions, governance, and reporting; use operational data to identify constraints and elevate issues with clear options and recommendations.
• Lead meetings and readiness reviews, maintain decisions and action ownership, and communicate concise updates to teams, leaders, sites, and external partners.
• Advance portfolio priorities and PMO practices through lessons learned, data-driven insights, coaching, and influence without direct authority.
• This position is located in Lafayette, CO. Travel up to 25%, primarily in US.

• Bachelor's degree and a minimum of 7 years of relevant experience, or an advanced degree with a minimum of 5 years. Degrees earned outside the United States must meet applicable equivalency requirements.
• Demonstrated experience leading complex, interdependent cross-functional projects or programs in medical devices, regulated products, manufacturing, operations, supply chain, product lifecycle management, or a comparable environment.
• Strong operational knowledge of released or commercialized products, including translating technical, quality, regulatory, supply, and business requirements into executable plans.
• Direct experience leading complex technical or operational work with OEMs, contract manufacturers, or external suppliers.
• Experience managing integrated schedules, budgets, risks, dependencies, governance, executive communications, and cross-functional…