Project Manager

About Us

NovelCath, a Cirtec company, specializes in the design and development of complex, minimally invasive, interventional medical technologies. We have delivered first-of-a-kind medical devices for the Interventional Cardiology, Structural Heart, Electrophysiology and Neuromodulation markets. 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 Project Manager position is primarily responsible for managing and coordinating development and manufacturing transfer of complex components and finished medical devices.

Key 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.

Requirements

• 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.
• Sponsorship or transfer of sponsorship, including OPT/F1 Visas, is not available for this role. Candidates must be able to commute on-site daily (Brooklyn Park, MN) without relocation to be considered.

Skills

• Experience with metals processing and Nitinol-based devices preferred.
• Exposure or working familiarity in a catheter device development environment is a huge plus.

Pay

The pay range for this role is $90,000 - $110,000 a year. The successful candidate’s starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match