Summary:
Conducts engineering research and development activities on projects of a very sophisticated nature containing technology in the areas of: biomechanics and mechanisms; molded, machined, and sheet metal parts. Supervises designers and technicians; guides and reviews their progress and evaluates / approves the results of their work. Personally contributes to development activity by providing original concept work overall, and performing some detail designs for complex parts of systems and sub-components.

Essential Duties and Responsibilities include the following.

* Conceive, design and develop novel spinal implants and instruments in accordance with established policies, goals, and objectives.
* Assist the development of new products and product concepts using existing and emerging technologies per design control requirements.
* Perform component and assembly design and solid modeling using SolidWorks CAD software for complex implant and instrument systems.
* Contribute to the development and authorization of SOPs, operational procedures, part and assembly drawings, test reports, MRB decisions, and other related documents.
* Participate in and lead, as applicable, design reviews.
* Prepare and review information for patent applications.
* Perform component and process vendor identification and support. Assist in the effort to verify and validate new product designs.
* Prepare test protocols and reports.
* Prepare support materials for regulatory submissions including 510(k), PMA, and CE mark.
* Work with Marketing and directly with customers; help ensure design and testing of prototypes to meet market and customer requirements.
* Maintain sufficient and accurate technical records in an engineering notebook per company policies.
* Support material review board and corrective action requirements as they relate to R&D support and personnel.

Knowledge, skills, and abilities required:

* Must have a minimum of 1 year of CAD experience with some proven mechanical design software system
* Must have a demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
* Must have the ability to professionally and effectively present information to, and receive feedback from staff as well as external partners.
* Must have experience in, and understanding of, laboratory and mechanical testing processes and practices.
* Must have a good understanding of mechanical testing systems.
* Some exposure to, and knowledge of, mechanical design and manufacturing processes and environments (bioengineering or biomechanical engineering preferred.)
* Some understanding of quality standards, and manufacturing operations and how those departments relate to R&D mechanical engineering.
* Must be able to demonstrate strong analytical and problem solving skills, as well as a good understanding of the product development process.
* Comfortable working with and seeking optimum solutions with mechanical engineering team members, regulatory, clinical, quality, marketing, and manufacturing.
* Strong creative ability as well as IP knowledge.

Education/Experience:
Bachelor’s degree in Mechanical Engineering from a top engineering school, Master’s degree or BS in biomechanical or biomedical engineering preferred
Minimum of 1 year of engineering work experience.