Sr. Project Manager

Description

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 leading and managing development projects and manufacturing transfer of complex components, sub-assemblies and/or medical devices.

• 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.

• 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 21
  
  CFR
  820 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

• Experience with Class III medical devices
• CDMO experience

Competitive market salary range from $,000 based on qualifications and previous experience.

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

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.