DescriptionPosition Summary: The Sr. Project Manager position is primarily responsible for leading and managing development projects and manufacturing transfer of complex components, sub-assemblies and/or medical devices.
Key Responsibilities:- Provide day-to-day leadership for assigned medical device projects, including coordination of product development activities and manufacturing transfer efforts for components, sub-assemblies, and finished devices.
- Develop, maintain, and update comprehensive project schedules, work plans, task tracking tools, and risk management documentation to support effective execution and prioritization of project work.
- Coordinate and integrate efforts across engineering, quality, operations, and other functional teams to ensure timely completion of project objectives and milestones.
- Monitor project performance related to schedule, cost, technical challenges, and risk exposure, and prepare clear and accurate status updates for internal leadership and external stakeholders.
- Identify potential project risks and issues early and implement appropriate mitigation strategies, corrective actions, or preventive measures to minimize impact.
- Ensure Design History File documentation is established and maintained in accordance with internal procedures and applicable FDA (21 CFR 820) and ISO 13485 requirements.
- Support project teams in defining, documenting, and maintaining product requirements, verification activities, and testing plans throughout the project lifecycle.
- Serve as the primary customer point of contact for assigned projects, managing routine communications, meetings, and site visits as appropriate.
- Coordinate with functional and site leadership to align internal resources and capacity in support of project timelines and delivery commitments.
Must Have:- Minimum BS in a relevant engineering discipline
- At least 5 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
- 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 Class III medical devices
- CDMO experience
Salary Range: Competitive market salary range from $110,000-130,000 based on qualifications and previous 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.
