Project Manager

Job Title: Project Manager

Location: Arvada, CO

Experience: 12+ Years

Employment Type: Contract

Work Model: Onsite

Duration: 12+ Months

Domain: Project Management / Manufacturing Transfer / Quality & Regulatory

Industry: Medical Devices / Life Sciences / Contract Manufacturing

Job Summary: Seeking an experienced Project Manager with strong experience in medical device manufacturing and plant/manufacturing transfers. The ideal candidate will manage cross-functional teams, CM/CMO relationships, project schedules, risks, resources, budgets, and transfer activities while ensuring compliance with applicable medical device quality and regulatory requirements.

Key Responsibilities

• Develop and maintain integrated project plans, schedules, milestones, budgets, and critical-path activities.
• Lead plant/manufacturing transfer strategy, execution, and stabilization activities.
• Coordinate transfer of BOMs, manufacturing instructions, process specifications, test methods, validation protocols, equipment parameters, and production records.
• Coordinate with Contract Manufacturers (CMOs) on pilot builds, engineering builds, and production qualification runs.
• Drive cross-functional meetings, governance, decision-making, issue resolution, and executive reporting.
• Manage project risks, resources, timelines, budgets, and dependencies.
• Support supply continuity, inventory planning, logistics, warehousing, and distribution activities during transfer.
• Coordinate SME knowledge transfer and training/certification of receiving-site personnel.
• Lead risk assessments covering supply, regulatory, operational, capacity, and business-continuity risks.
• Track project KPIs, expenditures, CAPEX, savings, milestones, and overall project performance.

Quality & Regulatory

• Ensure compliance with FDA 21 CFR Part 820, ISO 13485, GMP, and applicable EU MDR requirements.
• Support QMS transfer activities and validation strategy.
• Experience with IQ/OQ/PQ, Process Validation, Cleaning Validation, and Sterilization Validation is preferred.

Required Qualifications

• 12+ years of Program/Project Management experience.
• 5+ years of Medical Device industry experience, preferably sterile disposable devices.
• Strong Manufacturing/Plant Transfer and Contract Manufacturing/CMO experience.
• Experience with medical device quality systems and regulatory requirements.
• Strong knowledge of project scheduling, resource planning, risk management, and budget management.
• Experience with Microsoft Project or similar project management tools.
• Strong cross-functional leadership, stakeholder management, communication, and problem-solving skills.
• Lean Manufacturing / Six Sigma experience preferred.
• PMP or equivalent certification preferred.

Preferred Experience

• Product and process transfer
• BOM/work instruction/test method transfer
• QMS and validation transfer
• Sterile disposable medical devices
• Pilot, engineering, and production qualification builds
• Supply Chain and Procurement coordination
• CAPEX/financial tracking
• Executive presentations and governance meetings

Benefits : Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Equal Employment Opportunity : Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.