Principal Project Manager

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

Job Description

• Lead multiple complex MDR implementation and released-product change projects from initiation through completion
• Drive execution across Engineering, Quality, Regulatory Affairs, Manufacturing, Operations, Supply Chain, Supplier Quality, and external partners
• Work directly with OEMs, contract manufacturers, and suppliers to establish requirements, deliverables, timelines, milestones, and readiness expectations
• Coordinate supplier and OEM activities associated with component/device qualification, technical transfer, and implementation of design requirements
• Translate technical, operational, quality, regulatory, and supply-chain requirements into executable project plans
• Coordinate released-product changes involving components, suppliers, manufacturing processes, specifications, packaging, labeling, and quality systems
• Manage project schedules, budgets, resources, risks, dependencies, decisions, and governance
• Identify operational or supplier constraints and establish recovery plans to protect product availability and continuity of supply
• Lead cross-functional meetings, readiness reviews, issue resolution, and executive-level project updates
• Hold internal teams and external partners accountable to milestones while influencing without direct authority
• Drive decisions and escalations when supplier, manufacturing, technical, or operational issues threaten project timelines
• Support PMO process improvements, lessons learned, and portfolio execution

Job Description: Insight Global is seeking a Principal Project Management Specialist for a top medical device client. This individual will lead complex, cross-functional projects supporting released medical device products, with a heavy focus on supplier/OEM management, operational execution, component and device qualification, technical transfer, and compliance-driven product changes. The ideal candidate has strong experience partnering with OEMs, contract manufacturers, and suppliers to translate technical and design requirements into executable plans while coordinating Engineering, Quality, Regulatory, Manufacturing, Operations, and Supply Chain stakeholders. This person will own schedules, risks, dependencies, milestones, and escalations while helping protect product availability and continuity of supply.

Skills and Requirements

• Bachelor’s degree + 7+ years of relevant experience OR advanced degree + 5+ years
• Strong Project/Program Management experience leading complex, cross-functional technical or operational projects
• Strong supplier/OEM/contract manufacturing experience
• Experience working directly with external manufacturers or suppliers to qualify components and/or medical devices
• Strong supplier qualification and technical transfer experience, ideally from a design/engineering perspective
• Experience translating Medtronic/internal design and technical requirements into supplier or OEM execution requirements
• Experience with released/commercialized products and managing changes after product launch
• Strong operations/manufacturing background, including understanding how design, quality, supply chain, manufacturing, and supplier activities connect
• Experience managing integrated schedules, risks, dependencies, resources, budgets, governance, and cross-functional decisions
• Ability to influence OEMs, suppliers, internal teams, and leadership without direct authority
• Experience operating in a regulated, technical, manufacturing, medical device, or comparable product environment
• Strong communication, problem-solving, escalation, and stakeholder-management skills
• Medical device industry experience
• EU MDR implementation or MDR transition experience
• Regulatory remediation or compliance program experience
• Supplier transitions, component qualification, component obsolescence, or continuity-of-supply experience
• Manufacturing/process change and validation experience
• Knowledge of medical device quality systems, design controls, change controls, risk management, and configuration management
• Engineering, Operations, Supply Chain, or scientific degree
• MBA or advanced technical degree
• PMP certification
• Lean or Six Sigma certification
• Experience using AI-powered tools to improve analysis, productivity, communication, or decision-making

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [e-mail].