Medical Device Project Manager — On‑Site (Brooklyn Park)

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

Benefits offered by this job

Benefits package

Job summary

Cirtec Medical in Brooklyn Park, MN is seeking a Project Manager to lead development and manufacturing transfer of complex medical devices. You will coordinate cross-functional teams, manage scope, schedule, and budget, and communicate with customers.

The ideal candidate has a BS in engineering and 3+ years in medical device project management, with strong knowledge of ISO 13485 and FDA 21 CFR 820. On-site work required with no relocation.

Qualifications

• Minimum BS in a relevant engineering discipline with 3+ years of experience within the medical device industry.
• Minimum 2 years of experience in project / program management of medical device development.
• Must possess strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 based Quality Systems and Design Control.
• Must be able to interpret technical drawings, product requirements, design specifications and relevant technical documents.
• Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders.
• Strong internal communication to develop relationships with cross-functional teams.
• Good to have: Experience with metals processing and Nitinol-based devices preferred.
• Good to have: Exposure or working familiarity in a catheter device development environment is a huge plus.

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 project risk registers that enable the team to execute project activities based on well-defined prioritization.
• Coordinates activities across different functional groups to ensure successful completion of project goals and milestones.
• Tracks project health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
• Proactively anticipates project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
• Serves as a point of contact with external customers. Coordinates and directs customer meetings and visits as well as day-to-day customer communication.
• Complies with company, quality and safety standards, policies, and procedures.

Skills

Project management

Cross-functional leadership

Risk management

Stakeholder communication

Education

Bachelor's degree in engineering

Job description

Cirtec Medical in Brooklyn Park, MN is seeking a Project Manager to lead development and manufacturing transfer of complex medical devices. You will coordinate cross-functional teams, manage scope, schedule, and budget, and communicate with customers.

The ideal candidate has a BS in engineering and 3+ years in medical device project management, with strong knowledge of ISO 13485 and FDA 21 CFR 820. On-site work required with no relocation.