Development Engineer K2M
THIS JOB HAS EXPIRED
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.
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.
Bachelor?s degree in Mechanical Engineering, Master?s degree or BS in biomechanical or biomedical engineering preferred. Experience in Orthopedics preferred.
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.
Basic understanding of GD&T
K2M commits to our coworkers, applicants and community to provide employment opportunities to everyone based solely on ability.
K2M is an EQUAL OPPORTUNITY EMPLOYER.
||751 Miller Drive, SE |
Leesburg, VA 20175
THIS JOB HAS EXPIRED