Prin PD Project Mgmt Spec - Exempt

Location: On-site; Lafayette, CO or Mounds View, MN

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.

A Day in the Life

• 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.

Qualifications

To thrive in this role, you must have:

• 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 decisions.
• Ability to influence, establish accountability, negotiate, resolve conflict, and communicate complex information across teams, leaders, executives, and external organizations without direct authority.
• Ability to work independently through ambiguity, changing priorities, resource constraints, and issues requiring structured investigation and practical problem solving.

Nice to Have

• Experience with EU MDR implementation, regulatory remediation, compliance programs, or global released-product lifecycle management.
• Experience leading supplier transitions, manufacturing or process changes, capacity or continuity initiatives, component obsolescence, quality improvement, remediation, or cost-improvement programs for commercialized products.
• Working knowledge of medical-device quality systems, design and change controls, validation, risk and configuration management, and applicable regulatory standards.
• Degree in Engineering, Operations, Supply Chain, a scientific discipline, or equivalent industry experience; an advanced technical degree or MBA is preferred.
• PMP, Lean, Six Sigma, or comparable project-management or operational-excellence certification.
• Business acumen and experience using AI-powered tools to improve analysis, productivity, communication, decisions, or business outcomes.

About Us

Together, we can change healthcare worldwide. At our company, we push the limits of what technology, therapies, and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Interview Process

• How many rounds? 4
• Video vs. phone? Video, on-site if possible.