<p>Job Title: Product Development / Design Engineer</p> <p>ID#: J-xxxx</p> <p>Department: Engineering and Operations</p> <p>Job Description:</p> <ul> <li>Purpose and Scope </li></ul> <p>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.</p> <ul> <li>Responsibilities </li></ul> <p>Responsibilities include:</p> <ul> <li>Create, experiment with, and evaluate new product concepts </li><li>Participate in project brainstorming meetings </li><li>Capable of designing initial prototypes of specific concepts </li><li>Capable of developing and executing clinical and engineering testing protocols </li><li>Capable of troubleshooting and debugging prototypes </li><li>Perform engineering activities, including, ensuring customer requirements are met, maintaining compliance with quality system requirements, and participating in project status meetings </li><li>Interface with clients regarding project status </li><li>Assure project proceeds in accordance with the Synectic Design Control system. </li><li>Perform according to detailed project timeline (start up to project completion). </li><li>Participate in material, component and device assessment and selection for devices and implants </li><li>Develop and communicate to customers results using Microsoft powerpoint or word, as applicable </li><li>Organization Relationships </li></ul> <p>The Product Development / Design Engineer reports directly to the Engineering Manager of the company. The Senior Product Development / Senior Design Engineer works closely with internal and external technical teams such as other engineers, industrial designers, clinicians and vendors.</p> <p>Job Requirements:</p> <ul> <li>Education and Training </li><li>A minimum of a 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 </li><li>Minimum of five or more years of demonstrated success in product design and development engineering roles, specifically including the following experience and qualifications: </li><li>Success in advancement of multiple new product development projects, from project startup through commercialization </li><li>Demonstrated aptitude for creative, "out of the box" thinking, and translating customer needs into product ideas </li><li>Strong mechanical and problem solving abilities </li><li>Demonstrated ability to function independently and effectively within a multi-disciplinary team </li><li>Technical Requirements </li><li>Knowledge of product development and manufacturing </li><li>Skilled at thinking strategically, innovating and applying technical knowledge to complex problems </li><li>Proficient with recent versions of 3D CAD applications (SolidWorks preferred) </li><li>Working knowledge of in-house machine shop capabilities and safety procedures. </li><li>Knowledge of rapid prototyping techniques, molding and extrusion methods, metal processes and components and common medical device assembly processes </li><li>Familiarity with operation of typical mechanical laboratory equipment, as necessary for material, component and device performance evaluation </li><li>Solid data analysis, data management, basic statistics and experimental design skills </li><li>Experience with design, fabrication and validation of simulated use and standardized product performance tests </li><li>Knowledge of polymer and elastomer properties, and common fabrication methods and limitations </li><li>Very proficient with PC-based office tools, such as Microsoft Word, Excel, Outlook, Powerpoint and Project </li><li>Basic knowledge of classic stress analysis, Finite Element Analysis and mold flow analysis </li><li>Capable of conducting patent and competitive product research on the internet. </li><li>Experience and working knowledge of quality systems </li></ul>