Medical Device PM - Development & Transfer Lead

Cirtec Medical; Minneapolis (MN); On-site; USD 90,000 - 110,000; Full time

Job summary

Cirtec Medical seeks a Project Manager to coordinate development and manufacturing transfer of complex medical devices and components. You will build detailed plans, manage risks, and liaise with cross-functional teams to meet milestones.

Candidates should have a BS in engineering and 3+ years in medical devices, plus 2+ years in project management and strong knowledge of ISO 13485/FDA 21 CFR 820. On-site employment in Brooklyn Park, MN is required.

Qualifications

• BS in engineering with 3+ years’ experience in the medical device industry.
• 2+ years in project/program management for medical device development.
• Solid understanding of ISO 13485 and FDA 21 CFR 820 quality systems and design controls.
• Ability to read technical drawings and interpret product requirements.

Responsibilities

• Manages and coordinates development and manufacturing transfer of complex components, sub-assemblies and finished medical devices.
• Generates and maintains detailed project plans, task lists and risk registers.
• Coordinates activities across functional groups to reach goals and milestones.
• Tracks project health: schedule, budget, risks; prepares status reports for stakeholders.
• Prepares risk mitigations and corrective actions.
• Acts as primary customer contact; coordinates meetings and day-to-day communications.
• Compiles with company, quality and safety standards and procedures.

Skills

Project management

Quality systems

Communication

Design control

Education

Bachelor's degree in engineering

Job description

Cirtec Medical seeks a Project Manager to coordinate development and manufacturing transfer of complex medical devices and components. You will build detailed plans, manage risks, and liaise with cross-functional teams to meet milestones.

Candidates should have a BS in engineering and 3+ years in medical devices, plus 2+ years in project management and strong knowledge of ISO 13485/FDA 21 CFR 820. On-site employment in Brooklyn Park, MN is required.