About the position
The Product Development / 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 Product Development / 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
- 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
Requirements
- A minimum of a 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
- Success in advancement of multiple new product development projects, from project startup through 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
- 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
