Management Recruiters of Gastonia: Medical Device Recruiters

The client is involved in Orthopaedic Surgical procedures, involving both manufactured implants and biologics directed at spinal applications. The company is technically driven, has a flat organizational chart and generates an exceptional ratio of revenue per employee. Their success is driving growth in their technical team and in this role they are seeking individuals with demonstrable leadership success in the full breadth of Medical Device Product Development from Concept to Commercialization. (You may be asked to provide specific examples of your experience in this regard with client's recognition for the limits imposed by Non-Compete/Non-Disclosure Agreements.) Candidates must demonstrate the technical prowess required to understand the relationships between the Surgeon's desire and the practicalities of manufacturing as well as being cognizant of the importance of COGS as they relate to sales price/marketability and profitability. Communications skills will encompass the need to present and discuss projects at every level including Surgeons, Sales/Marketing, Internal Engineering, Quality Assurance and Regulatory Control, Internal Executive Management and External Suppliers.

The qualified candidate will have demonstrable experience in, or exposure to the full breadth of product development in a Medical Device environment including: Concept Development generated internally and through communications with Medical professionals; Design Control as defined by the cGMP's; Prototyping and Proof of Concept presentation; Development of implants and/or the associated devices used during surgery; Finalization of a robust manufacturing process in preparation for transfer to Operation (DFMA); Complete familiarity with documentation requirements as defined by both ISO and FDA. Depending upon the level of experience (i.e. Prod. Dev. Eng. vs. Sen. Prod. Eng.) the individual will either participate on new product development teams or lead the project as defined by the requirements of both Marketing and the end user. Strong written and verbal communications are a must. An ability to work cross-functionally with Sales/Marketing, Design Engineering, Manufacturing Engineering/Operations and Quality as well as provide clear and concise directions to OSV (Outside Service Vendors) involved in both the prototyping and manufacture of the products.