Project Manager – Medical Device Manufacturing Transfer

Tap Growth ai; Arvada (CO); On-site; USD 120,000 - 160,000; Full time

Job summary

Tap Growth ai is seeking an experienced Program Manager to lead medical device manufacturing transfers in Colorado. You will oversee cross-functional teams, BOMs, process documentation, validation activities, and risk management to ensure supply continuity and regulatory compliance.

Candidates should have strong leadership, ISO 13485, FDA 21 CFR Part 820, EU MDR, GMP, IQ/OQ/PQ, and certifications like PMP, Lean, or Six Sigma. The role involves budgets, timelines, and executive reporting.

Qualifications

• Experience leading medical device manufacturing transfers.
• Strong cross-functional team leadership.
• Experience with BOMs, process documentation, supply continuity.
• Budgets, risk management, and executive reporting experience.
• PMP, Lean Manufacturing, and Six Sigma are preferred.

Skills

Program management

Manufacturing transfer

Medical device compliance

PMP

Lean Manufacturing

Six Sigma

Cross-functional leadership

Tools

Microsoft Project

Job description

Skills Required:Program management, manufacturing transfer, medical device compliance, ISO 13485, FDA 21 CFR Part 820, EU MDR, GMP, IQ/OQ/PQ, process validation, risk management, and Microsoft Project.
Experience:Strong leadership in medical device manufacturing transfers, preferably sterile disposable devices. Must manage cross-functional teams, BOMs, process documentation, supply continuity, validation, budgets, risks, and executive reporting. PMP, Lean Manufacturing, and Six Sigma are preferred.