Project Manager – Medical Device Manufacturing Transfer

RAPSYS TECHNOLOGIES PTE LTD; Arvada (CO); On-site; USD 120,000 - 180,000; Full time

Job summary

RAPSYS TECHNOLOGIES PTE LTD in Colorado is seeking a senior program management lead to drive medical device manufacturing transfers and ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR and GMP standards.

The role requires strong cross-functional leadership, BOM and documentation management, and oversight of validation activities, budgets, and risk mitigation. PMP/Lean/Six Sigma preferred.

Qualifications

• Strong leadership in medical device manufacturing transfers.
• Experience managing cross-functional teams, BOMs, and process documentation.
• PMP, Lean Manufacturing, and Six Sigma are preferred.

Responsibilities

• Lead cross-functional teams through manufacturing transfers, preferably sterile disposable devices.
• Oversee BOMs, process documentation, supply continuity, validation, budgets and risk management.
• Provide executive reporting on project status, budgets and risks.

Skills

Program management

Manufacturing transfer

Medical device compliance

ISO 13485

FDA 21 CFR 820

EU MDR

GMP

IQ/OQ/PQ

Process validation

Risk management

Microsoft Project

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.