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.
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.
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.
Proficient in Microsoft Project, Excel, PowerPoint, and SolidWorks or ProE.
Carries out some supervisory responsibilities in accordance with the organization's policies and applicable laws as dictated by superiors. Responsibilities may include interviewing and training employees and directing the work of designers.