Design Engineer

Job Description:

The Design Engineer is responsible for developing, engineering, and designing medical devices, systems, disposable and reusable surgical instruments, as well as capital equipment and laboratory equipment. The position is with a fast and flexible medical device consulting firm. The Design Engineer reports directly to the Engineering Manager and will work closely with the team of engineers. The Design Engineer works closely with internal and external technical teams, such as other engineers, industrial designers, clinicians, and vendors.

Responsibilities Include:

• Conceptualizing, analyzing, designing, assembling, debugging, and troubleshooting iterative prototypes of specific concepts
• Capable of developing and executing clinical and engineering testing protocols and documenting results in reports and presentations
• Able to work both independently and on project teams to accomplish project goals
• Participating in project status meetings internally with team members and externally with clients
• Perform according to detailed project timeline and project proposals (start-up to project completion)
• Develop and communicate results to customers using various MS Office software

Education and Training Requirements:

• A minimum four-year college degree in engineering or science, or equivalent experience, is required
• Minimum of five or more years of demonstrated success in product design and development engineering roles, specifically including the following experience and qualifications:
  • Success in advancing multiple new product development projects, from project startup to commercialization
  • Demonstrated aptitude for creative, “out of the box” thinking and translating customer needs into product ideas
  • Strong mechanical and problem-solving abilities
  • Demonstrated ability to function independently and effectively within a multi-disciplinary team

Technical Requirements:

• Knowledge of medical product development and manufacturing within the mechanical medical device and surgical instrumentation industry
• Skilled at thinking strategically, innovating, and applying technical knowledge to complex problems
• Proficient with recent versions of 3D CAD applications (SolidWorks preferred)
• Working knowledge of in-house machine shop capabilities and safety procedures
• Knowledge of rapid prototyping techniques, molding and extrusion methods, metal processes and components, and common medical device assembly processes
• Familiarity with tissue lab, cadaver lab, and animal lab operations and procedures
• Familiarity with the operation of typical mechanical laboratory equipment (force columns, data loggers, cycle testers, optical measurement systems)
• Solid data analysis, data management, basic statistics, and experimental design skills
• Experience designing, fabricating, and validating simulated use and standardized product performance tests
• Knowledge of polymer and elastomer properties and common fabrication methods and limitations
• Very proficient with PC-based office tools, such as Microsoft Word, Excel, Outlook, PowerPoint, and Project
• Basic knowledge of classic stress analysis, Finite Element Analysis, and mold flow analysis
• Capable of conducting patent and competitive product research on the internet
• Experience working in an ISO quality system