Sr. Project Manager - NovelCath

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, 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, actively seeking opportunities for improvement to enhance our support for clients.

About the role

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

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.
• Manage transfers to another location within the network and 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, including 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.

Requirements

• 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.
• Strong understanding and working knowledge of ISO 13485 and FDA 21CFR820 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.
• Proficiency in MS Project and other MS Office software.
• Able to read, write, and speak fluent English with excellent communication skills, both written and oral.
• Willingness to travel if required.

Nice to have

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

Pay

Salary range: $115,000 to $135,000 based on skills and experience.

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.