US, US, OH - West Carrollton
Minimum Level of Education Required: Bachelors Degree
Percentage of Travel: Up to 25%
Location: OH - West Carrollton
Support the development, launch and production of products.
· Create and layout all phases of new product development from concept layout to production.
· Interact with interdepartmental personnel such as clinical advisors, marketing, purchasing, and manufacturing to create formal product specifications.
· Make engineering, manufacturing, and materials decisions based upon input specifications.
Work effectively with peers within development teams to achieve project objectives.
Understand basic anatomy and physiology of the spine and procedures for which products will de designed and developed. Understands basic concepts of biology as it pertains to bone and other connective tissues.
Create or direct the creation of detailed product designs and supporting documentation.
Proactively assemble necessary information and establishes informal working networks within the company to solve departmental challenges.
Understand requirements of project plans and focuses activities on meeting plan objectives.
Interface with vendors on technical issues.
Design and develop medical devices relevant to spinal procedures in accordance to ISO and FDA regulations.
If applicable, experience and project creative engineering drawings, including assignment of dimensions and tolerance to designs.
Support all engineering documentation activities related to product development, validation, launch, and production.
Assist in the cadaver lab.
Assemble and troubleshoot prototype and production products.
Interface with medical professionals with respect to design and development of devices.
Interface with other company personnel in the management of project responsibilities.
Create and maintain documentation relevant to design control and other applicable regulatory requirements.
Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485.
Bachelor’s degree (BSME) or equivalent and three to five years’ related experience; or equivalent combination of education and experience. Orthopedic and implant experience required.
Proficient and accurate with Pro Engineer CAD software, word processing (Word), spreadsheets (Excel), charting, flow-charting, and graphs. Competency in navigating the Internet.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.