Manufacturing Transfer Project Lead - Medical Devices

Intellectt Inc; Arvada (CO); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

None

Job summary

Intellectt Inc. seeks an experienced Project Manager to lead manufacturing and plant transfer initiatives in a regulated medical device environment. The role requires driving integrated project plans, coordinating product and process transfers, and ensuring timelines and quality standards are met.

Ideal candidates will have 12+ years in PM, 5+ years in medical devices, and strong governance and cross-functional collaboration skills. This is an onsite role based in Arvada, CO.

Qualifications

• 12+ years in project or program management.
• 5+ years in the medical device industry.
• Experience managing manufacturing transfer projects.
• Coordinate with CMOs or external partners.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, GMP.
• Experience with IQ/OQ/PQ and validation.
• Strong scheduling, risk, and budget management.
• Proficiency with Microsoft Project.

Responsibilities

• Develop and maintain integrated project plans with schedules, budgets, milestones.
• Execute manufacturing and plant transfer strategies with CMOs.
• Support governance structures and cross-functional workstreams.
• Drive decision-making and resource allocation across stakeholders.
• Monitor progress, risks, KPIs, and dependencies.
• Prepare status reports and governance materials.
• Facilitate cross-functional meetings to align teams.

Job description

Intellectt Inc. seeks an experienced Project Manager to lead manufacturing and plant transfer initiatives in a regulated medical device environment. The role requires driving integrated project plans, coordinating product and process transfers, and ensuring timelines and quality standards are met.

Ideal candidates will have 12+ years in PM, 5+ years in medical devices, and strong governance and cross-functional collaboration skills. This is an onsite role based in Arvada, CO.