Sr. Project Manager

About us:

Novel Cath 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!

The Sr. Project Manager position is primarily responsible for managing and coordinating development projects and manufacturing transfer of complex components, sub-assemblies and/or medical devices.

• 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

• Minimum BS in a relevant engineering discipline
• At least 5 years of experience within the medical device industry
• Minimum 5 years of experience in project / program management of medical device development.
• Must possess strong understanding and working knowledge of ISO 13485 and FDA 21
  
  CFR
  820 based Quality Systems and Design Control.
• Ability to condense and communicate complex technical ideas, project status and risks to internal and external stakeholders.
• Provide clear, data-driven program updates (KPIs, risks, milestones) to executive leadership
• Facilitate decision-making and escalation of critical issues
• Must have proficiency in MS Project and other MS Office software.
• Must be able to read, write and speak fluent English, and must possess excellent communication skills, both written and oral.
• Willingness to travel, if required.

• Experience with metals processing, Catheters, and Nitinol-based devices preferred but not required.

115,000 to 135,000 based on skills…