My name is
Bipasa, and I'm reaching out from
Intellectt Inc. regarding an exciting opportunity for
Project Manager based in
Arvada, COJob Summary Looking for an experienced Project Manager with strong expertise in medical device manufacturing transfers, program management, and cross-functional leadership. The candidate will manage end-to-end manufacturing transfer activities, ensuring project timelines, quality, regulatory compliance, and continuity of supply.
Key ResponsibilitiesDevelop and manage integrated project plans, schedules, budgets, milestones, and deliverables.
Lead manufacturing plant transfer strategy and execution.
Coordinate product, process, and technical documentation transfers between OEM and contract manufacturing teams.
Manage BOM, manufacturing instructions, process specifications, test methods, and validation documentation.
Coordinate pilot builds, engineering builds, and production qualification runs.
Ensure compliance with FDA 21 CFR Part 820, EU MDR, ISO 13485, and GMP requirements.
Coordinate QMS transfer and validation activities, including IQ, OQ, and PQ.
Manage supply chain readiness, inventory planning, and continuity of supply.
Identify project risks, develop mitigation plans, and resolve cross-functional issues.
Track project budgets, KPIs, milestones, and provide regular updates to leadership.
Required Qualifications- 12+ years of Program/Project Management experience.
- 5+ years of Medical Device industry experience.
- Sterile disposable medical device experience preferred.
- Experience in manufacturing transfer and process transfer activities.
- Knowledge of Lean Manufacturing, Six Sigma, and Quality Systems.
- Understanding of FDA 21 CFR Part 820, EU MDR, ISO 13485, and GMP.
- Strong experience with Microsoft Project, project scheduling, resource planning, and risk management.
- PMP certification preferred.
- Strong leadership, stakeholder management, and cross-functional coordination skills.
Bipasa Swain
Intellectt Inc.7329976610 | Ext: 300bipasa.s@intellectt.com