Cirtec Medical ยท 3 days ago
Sr. Project Manager
Cirtec Medical has been a leading outsourcing partner for complex medical devices for over three decades. The Sr. Project Manager is responsible for leading and managing development projects and manufacturing transfers of complex components and medical devices, ensuring effective execution and alignment across teams.
ManufacturingMedical Device
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
Qualification
Required
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
Preferred
Experience with Class III medical devices
CDMO 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
Company
Cirtec Medical
Stellar Technologies is manufacturer of precision components and assemblies.
H1B Sponsorship
Cirtec Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (4)
2022 (2)
2021 (3)
2020 (8)
Funding
Current Stage
Late StageTotal Funding
unknown2016-08-01Acquired
Recent News
2025-10-02
2025-09-17
2025-08-29
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