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Senior Program Manager - Enfield, United States - Cirtec Medical Corporation
Description
This position is located on-site in Enfield, CT.
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
JOB SUMMARY
The Sr. Program Manager is mainly responsible for leading and managing development and manufacturing
transfer of complex Class II and III medical devices.
ESSENTIAL RESPONSIBILITIES
• Leads and manages development and manufacturing transfer of complex Class 2 and 3 medical
devices including active implants, implantable leads, surgical devices and external use devices
• Generates and maintains detailed project plans, task lists and project risk registers that enable the
team to execute activities based on well-defined prioritization
• Manages cross-functional team assigned to the functional segment to ensure successful completion of
program goals and milestones, and adequate utilization of resources
• Tracks program 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 program 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
• Contributes to development, quality and risk management activities, and acts as backup to engineers
and technical staff on assigned programs as required
• Serves as the principal contact with external customers. Coordinates and directs customer meetings
and visits, and day-to-day customer communication
• Manages internal resources to meet program goals and milestones. Works with internal management
to ensure appropriate resources have been assigned
• Assists business development team with definition of program scope, timeline, and budget to support
preparation of proposals, quotations, and change orders for customers
• Manages, mentors and provides guidance to other program manager(s) in the functional group
• 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.
QUALIFICATIONS
• Minimum BS in Biomedical / Mechanical / Electronics / Computer Engineering with at least 10 years of
experience within the medical device industry.
• Minimum 5 years of experience in project / program management of medical device development
• Experience with neuromodulation devices, active implant devices and/or implantable lead assemblies
highly preferred
• Demonstrated ability to lead medical device development programs from early stage design through
verification/validation, and transfer to production
• 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
WHAT WE OFFER
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.
