Principle Project Manager

Insight Global (United States); Lafayette (CO); On-site; USD 120,000 - 180,000; Full time

Job summary

Insight Global is seeking a Principal Project Management Specialist to lead complex, cross-functional MDR implementation and released-product changes for top medical device programs.

You will partner with OEMs, contract manufacturers, and suppliers to translate design requirements into executable plans while coordinating Engineering, Quality, Regulatory, Manufacturing, Operations, and Supply Chain stakeholders.

Qualifications

• Bachelor's degree or higher with 7+ years of relevant experience, or advanced degree with 5+ years.
• Experience leading complex, cross-functional technical or operational projects.
• Strong supplier/OEM/contract manufacturing experience.
• Experience qualifying components and/or medical devices with external manufacturers.
• Supplier qualification and technical transfer experience, ideally from design/engineering.
• Translate design and technical requirements into supplier/execution plans.
• Experience with released products and managing changes post-launch.
• Operations/manufacturing background connecting design, quality, supply chain, and manufacturing.
• Ability to influence OEMs, suppliers, internal teams, and leadership without direct authority.

Responsibilities

• Lead multiple complex MDR implementation and released-product changes from initiation through completion.
• Drive execution across Engineering, Quality, Regulatory Affairs, Manufacturing, Operations, and Supply Chain.
• Work directly with OEMs, contract manufacturers, and suppliers to establish requirements and timelines.
• Coordinate supplier and OEM activities for component/device qualification and technical transfer.
• Translate requirements into executable project plans and governance structures.
• Manage schedules, budgets, risks, resources, and governance; escalate as needed.
• Identify constraints and develop recovery plans to protect product availability.
• Lead cross-functional meetings, readiness reviews, and executive updates.
• Hold internal and external teams accountable to milestones while influencing without authority.
• Support PMO process improvements and portfolio execution.

Skills

Project Management

Cross-functional Leadership

Supplier/OEM Management

Regulated Medical Device

Stakeholder Management

Communication Skills

Problem Solving

Escalation Management

Technical Transfer

Schedule Management

Education

Bachelor's degree

MBA or Advanced Degree

PMP Certification (Pluses)

Job description

• 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

Plusses:

• 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

Day-to-Day:

• 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.