Responsible for design and technical development in the area new product development with a focus on new innovation products. Works with Manufacturing and Project Management to ensure smooth production startup. Provides technical (design or process) engineering support for existing products and continuation engineering initiatives. Provides advanced technical leadership within the engineering group. **Summary** Responsible for design and technical development in the area new product development with a focus on new innovation products. Works with Manufacturing and Project Management to ensure smooth production startup. Provides technical (design or process) engineering support for existing products and continuation engineering initiatives. Provides advanced technical leadership within the engineering group. **Essential Duties and Responsibilities** include the following. (Other duties may be assigned.) **Design Engineering:** - Designs and develops products primarily outside of existing product lines. - Leads R&D investigation into new materials and design and or/manufacturing techniques. - Generates product development documentation as needed. - Provides input on technical matters related to product design. - Shows expert knowledge of the CAD system(s), advanced analysis tools and/or manufacturing processes. - Investigates new materials as well as new manufacturing techniques. - Able to makes decisions on advanced technical matters related to product design. - Able to demonstrate an in-depth understanding of IP and patent concepts and communicate concepts with engineering staff. - **Project Management:** - Works closely with project engineers to develop and understand project schedules (and work within them). - Communicates with manufacturing and project management on a regular basis throughout the project. - Communicates with OEMs and customers on other technical matters as needed. - Develops cost estimates for projects and products. - **Quality Assurance:** - Generates quality systems and project related documentation as needed. (i.e.. DHF documents, work orders, charters). - Understands and follows engineering related and overall company processes. - Experience with following processes of ISO 9001. - Preferred experience with ISO 13485, ISO 14971, FDA and MHLW requirements. - **Personal Development:** - Attends all relevant training. - Keeps abreast of relevant developments in technology. - Participates in clinical evaluations. - Actively pursuing further training and education. - CAD mentor to Jr. Mechanical Designers and entry level Engineers - **Leadership and Supervision:** - Able to provide technical guidance and support to junior engineers and interns. - Advises staff on CAD related problems and capabilities. - Able to provide technical leadership/mentoring within engineering. - Able represent Engineering in various capacities (CO, MRB, etc.) as required on technical issues. - **Other Skills:** - Demonstrates design, documentation, materials management, design for manufacturing, process management, design software management and troubleshooting/problem solving skills. - Demonstrates interpersonal, organizational and time management skills. - Experience with Microsoft Excel for spreadsheets, Microsoft Word for word processing and Microsoft Project for creating schedules. - Experience with manufacturing processes including injection molding, machining and assembly. - Prefer related product and equipment knowledge. **Qualifications** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above 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. **Education and/or Experience** Minimum of a Bachelor's degree (BS) in engineering from a four year college or university; and at least eight years related experience and/or training; or equivalent combination of education and experience. **Physical Demands** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; climb or balance and stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision, depth perception and ability to adjust focus **Work Environment** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The employee is occasionally exposed to toxic or caustic chemicals and risk of electrical shock. The noise level in the work environment is usually moderate.