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Senior Project Manager - Brooklyn Park, United States - Cirtec Medical Corporation
Description
This position is eligible for a $5,000 sign on bonus.
This position is located on-site based out of our corporate headquarters in Brooklyn Park, MN.
ABOUT THE COMPANY
Cirtec Medical is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today's most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.
Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers' devices to market. If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you
You are a part of:
The Engineering team consists of engineers with diverse backgrounds and expertise. The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.
JOB SUMMARY
The Sr. Project Manager position is primarily responsible for managing and coordinating development and manufacturing transfer of complex components and finished medical devices.
ESSENTIAL 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.
This is not a remote position.
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.
QUALIFICATIONS
• A Bachelor's degree (STEM engineering discipline preferred) and 5 years of experience required; or a combination of education and relevant work experience.
• Minimum 4 years of experience in project / program management of medical device development
• At least 4 years of product development experience
• Prefer medical device experience from a contract manufacturer
• 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
WHAT WE OFFER
In return, we offer you:
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.
EEO STATEMENT
Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer 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.
