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, and performing detail designs for complex parts of systems and sub-components. Manages small development projects, or selected portions of larger projects, under the supervision of a project engineer.

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.
• Take full responsibility for, and manage all product development activities for selected small projects or sub-sets of major projects as assigned.
• 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.
• Lead efforts 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.
• Working with Marketing and directly with surgeons, 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 and implement material review board and corrective action requirements as they relate to R&D.
• Prepare and maintain comprehensive design history files for projects they are involved in, in accordance with company and GMP requirements.

Knowledge, Skills, and Abilities required:
• Must Demonstrate solid understanding of GMP’s and Design Control. Must show examples of successful completion of the various phases of design control.
• Must have a minimum of 2 years 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 demonstrated proficiency with dimensioning and tolerances of mechanical component designs
• Must have experience in, and understanding of, laboratory and mechanical testing systems, processes and practices.
• Must have demonstrated ability to generate complex mechanical designs, preferably of medical devices.
• Must have familiarity with, and basic working knowledge of, typical manufacturing processes and machine shop equipment and environments.
• Must have a minimum of 2 years experience with 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 basic knowledge of the intellectual property process and the requirements thereof.
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed here are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience:
Bachelor’s degree in Mechanical Engineering from a top engineering school, Master’s degree or BS in biomechanical or biomedical engineering preferred.
A minimum of 2 years experience in product development, preferably in orthopedics.