CrossCart

CrossCart is a dynamic closely held company with cutting edge technology, a strong IP portfolio and excellent growth prospects. We are looking for a talented medical device project engineer and team leader to help us commercialize our xenograft-based ACL reconstruction device and develop new xenograft-based products.

The ideal candidate would initially take charge of setting up the facilities, manufacturing and quality operations for our lead product and would later lead our development, technology transfer and commercialization activities for our pipeline of other related products enabled by the company's extensive IP portfolio. This position is "hands on" with requisite senior level expertise in quality systems, regulatory reporting for manufacturing and ISO compliance.

Description:

The qualified candidate will utilize their strong background in commercial medical device development to design, validate and bring to market new products through 510K and PMA pathways.
Develop and report manufacturing processes for regulatory, validation and quality systems domestic and foreign.
Facilities management from design and construction to qualification and operations control.
Work with vendors and sub-contractors to optimize processes/products for quality and cost containment.
Skills to include a vision of product performance through the clinical evaluation processes.
Inter-disciplinary skills to include biological focus of applied enzymology and immunochemistry.
Provide product support for surgeons and clinical trials

Requires BSME, BSBME, or equivalent, Masters Degree preferred, with at least 5 years of tissue engineering and/or medical device experience. Must have a strong leadership abilities in regulatory manufacturing validation with emphasis on domestic and foreign quality systems. The ability to review, critically assess and implement technology is vital. Excellent written and oral communication skills are essential. Past experience must demonstrate a track record of innovative design and project completion from initial concept to product launch. The ability to interact and work effectively in a team environment is essential.