General Manager - medical device contract manufacturing

Cogmedix is a wholly owned subsidiary of The Coghlin Companies partnering with innovative companies to bring new medical and clinical product ideas to market.   Cogmedix will manufacture Class 1 and 2 medical and clinical devices and offers full worldwide shipping and fulfillment.  We are building a best-in-class management team by starting at the top, seeking a:

GENERAL MANAGER



Job Summary: 

The General Manager reports to the CEO of this privately-held contract manaufacturer and has overall management responsibility for the business providing leadership to all internal functions as well as clear intergration with all outsourced services and partners.  S/he will be hands-on professional capable and interested in building the organization and business from its ‘start-up’ to stabilization and beyond.  S/he will be able to leverage his/her existing network of medical device contacts to drive demand while comfortably establishing new contacts on the basis of the world-class, regulated contract manufacturing operations being created.

 

Essential Functions:General Business Management and Operational Leaderdship including P&L responsibility Business Development including Sales & Marketing Budget responsibility including creating and maintaining appropriate line item detail and implementing financial controls

 

Qualifications/Basic Job Requirements: BA/BS degree or equivalent in scientific or technical field; master’s degree a plus Familiarization with Regulatory Compliance including 21 CFR Part 820, ISO 13485:2003 and other relevant directives and regulatory requirements 15+ years Operations and/or management experience with 5+ years of FDA regulated Medical Device experience preferred, ideally in a fast-paced, flexible manufacturing environment Experience building a motivated cross-functional team in a fast-paced, flexible business environment Experience in a contract manufacturing environment beneficial but not required

 Cogmedix operations are based at our large manufacturing and engineering campus in Worcester, Massachusetts. Company benefits include shared medical insurance, life, LTD, dental, paid leave time, holidays, 401(k) plan, direct deposit, and a clean, pleasant working atmosphere.