DescriptionPosition Summary: 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.
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
- 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 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
- 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.
Good to have:- Experience with metals processing, Catheters, and Nitinol-based devices preferred but not required.
Salary Range: 115,000 to 135,000 based on skills and experience.
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.
