Location: Minneapolis,MN, USA
About us:
For over three decades, Cirtec Medical has been a leading provider of manufacturing solutions for complex Class II and III medical devices. We specialize in providing comprehensive services from design and development to manufacturing and finished device assembly. Our expertise spans active implants and neuromodulation, interventional cardiology, structural heart, minimally invasive surgical systems, smart orthopedics, and precision components.
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 challenge, you may be a perfect fit for our team!
Position Summary:
The Sr. 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
* Creates and maintains Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements
* Supports project team in establishing and maintaining product requirements and test plans
* Serves as the principal contact with external customers. Coordinates and directs customer meetings and visits, and day-to-day customer communication.
* Manages internal resource allocation to meet program goals and milestones. Works with internal management to ensure appropriate resources have been assigned.
* Reliable, consistent and punctual attendance is an essential function of the job
* Other duties as assigned. An individual in this position must be able to successfully perform the essential duties and responsibilities listed above.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position
Must Have:
* Minimum BS in a relevant engineering discipline with at least 5 years of experience within the medical device industry
* Minimum 4 years of experience in project / program management of medical device development
* Experience with metals processing and Nitinol-based devices preferred but not required
* 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
Working Environment:
Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.
Cirtec Medical Corporation considers everyone 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 its related companies fully endorse equal opportunity. 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 Cirtecs goal to create an enjoyable 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 stage of your career and life. 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.