Sr. Project Manager

Cirtec Services GmbH; Brooklyn Park (MN); On-site; USD 100,000 - 170,000; Full time

Job summary

Cirtec Medical seeks a Sr. Project Manager to lead development projects, manufacturing transfers, and ramp-up activities for complex medical devices and components.

You will be the primary customer interface, aligning project objectives with expectations and driving commercialization and continuous improvement efforts. This role requires a BS in an engineering discipline and at least 5 years of experience in the medical device industry, with the ability to collaborate across engineering,

Qualifications

• BS in a relevant engineering discipline.
• Minimum 5 years of experience within the medical device industry.

Responsibilities

• Lead and coordinate development projects, manufacturing transfers, and ramp-up activities for medical devices and components.
• Manage end-to-end program lifecycle including planning, execution, monitoring, and closure.
• Coordinate with engineering, quality, operations and other functions to ensure timely deliverables.
• Maintain project schedules, risk documentation, and status updates for leadership and customers.
• Identify and mitigate project risks and issues early with corrective actions as needed.

Skills

Project management

Lean Six Sigma

Cross-functional collaboration

Risk management

Education

BS in engineering

Job description

Description

About us:

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

The Sr. Project Manager position is primarily responsible for leading and coordinating development projects, manufacturing transfers, and production ramp-up activities for complex components, sub-assemblies, and/or medical devices. This role serves as a key customer interface, aligning project objectives with customer expectations, and ensuring successful execution of commercialization and continuous improvement efforts.

Key Responsibilities:

• Lead and coordinate assigned medical device projects, including development activities and manufacturing transfer efforts for components, sub-assemblies, and finished devices.
• Lead end-to-end program lifecycle including planning, execution, monitoring, and closure
• Transfers to another location, within the network
• Intercompany collaboration on programs
• Develop, maintain, and update project schedules, work breakdown structures, task plans, headcount planning and risk documentation to support effective execution and prioritization of project activities.
• Facilitate collaboration across engineering, quality, operations, and other functional teams to drive timely achievement of project deliverables and milestones.
• Monitor project performance with respect to schedule, cost, technical challenges, and risk exposure, with resource planning, and prepare clear status updates for internal leadership and external stakeholders.
• Identify potential project-level risks and issues early, and implement appropriate mitigation strategies, corrective actions, or preventive measures as needed.
• Ensure required Design History File documentation is created and maintained in compliance with internal procedures and applicable FDA (21 CFR 820) and ISO 13485 requirements.
• Ensure that cost is understood going into operations ramps.
• Lead problem-solving initiatives and corrective actions
• Maintain risk registers and contingency plans
• Apply Lean, Six Sigma, and continuous improvement methodologies
• Support project teams in defining, documenting, and maintaining product requirements, verification activities, and test plans throughout the development lifecycle.
• Serve as the primary point of contact for customers on assigned projects, coordinating routine communications, meetings, and site visits as appropriate.
• Coordinate with functional and site leadership to align internal resources and capacity in support of project objectives and delivery timelines

Must Have:

• Minimum BS in a relevant engineering discipline
• At least 5 years of experience within the medical device industry