DescriptionPosition Summary: The Project Manager position is primarily responsible for managing and coordinating development and manufacturing transfer of complex components and finished medical devices.
Key Responsibilities:- Manages and coordinates development and manufacturing transfer of complex components, sub-assemblies and finished medical devices.
- Generates and maintains detailed project plans, task lists and project risk registers that enable the team to execute project activities based on well-defined prioritization.
- Coordinates activities across different functional groups to ensure successful completion of project goals and milestones.
- Tracks project health in terms of schedule, budget, and technical risks and issues. Prepares and presents comprehensive project status reports to internal and external stakeholders.
- Proactively anticipates project risks and issues, and carefully formulates and implements risk mitigations and corrective/preventive actions.
- Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
- Complies with company, quality and safety standards, policies, and procedures.
Must Have:- Minimum BS in a relevant engineering discipline with 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.
Good to have:- Experience with metals processing and Nitinol-based devices preferred
Salary Range: The pay range for this role is $110,000 - $125,000 a year.
The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.
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.
