Senior Product Development and Design Engineer​

Job Description:

The Senior Product Development and Design Engineer is responsible for engineering and designing medical and nonmedical products. This person will work closely with the Engineering Manager. This position includes interfacing with clients, including project status meetings, product development project planning, tracking, and reporting. Working with other internal technical teams is a key responsibility, including clinicians, industrial designers, consultants, vendors, quality engineers, and other support personnel, as needed. The Senior Product Development and Design Engineer should have experience in the development of products for the medical device / healthcare industry/ consumer products. This person should have knowledge of creative concept development, clinical issues, prototype experience, and analytical ability.

Responsibilities Include:

• Create, experiment with, and evaluate new product concepts
• Participate in project brainstorming meetings
• Capable of designing initial prototypes of specific concepts
• Capable of developing and executing clinical and engineering testing protocols
• Capable of troubleshooting and debugging prototypes
• Perform engineering activities, including ensuring customer requirements are met, maintaining compliance with quality system requirements, and participating in project status meetings
• Interface with clients regarding project status
• Assure project proceeds in accordance with the Synectic Design Control system.
• Perform according to detailed project timeline (start up to project completion).
• Participate in material, component, and device assessment and selection for devices and implants
• Develop and communicate to customers results using Microsoft PowerPoint or Word, as applicable

Education and Training Requirements:

• A minimum four-year college degree in engineering or science, or equivalent experience, is required
• Strong listening, verbal and written communication skills required both with technical and non-technical people
• Minimum of ten 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 product development and manufacturing
• 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 operation of typical mechanical laboratory equipment, as necessary for material, component and device performance evaluation
• Solid data analysis, data management, basic statistics and experimental design skills
• Experience with design, fabrication and validation of 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 and working knowledge of quality systems