Design Engineer II

Responsible for design and project management in the area new product development with a focus on line extensions and new innovation products., · Design Engineering: Designs, develops and maintains products within and outside of existing product lines. Responsible for generation and approval of product development documentation on assigned projects. Shows advanced knowledge of the CAD system(s). Able to make decisions on intermediate technical matters related to product design. Investigates new materials as well as new manufacturing techniques.

· Project Management: Able to plan, schedule, and manage multiple intermediate product development and/or continuation engineering projects simultaneously. Communicates with OEMs and customers on product specifications and other technical matters. Provides inter/intradepartmental communication and information relating to project status. 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.

· Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below 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.

Other Duties as assigned

Education and/or Experience

Minimum of a Bachelor’s degree (BS) in engineering from a four year college or university; five or more years of related experience and; or equivalent combination of education and experience required.

Other Skills and Abilities

· Demonstrates design, documentation, materials management, design for manufacturing, process management and troubleshooting/problem solving skills required.

· Demonstrates interpersonal, organizational and time management skills required.

· Demonstrates good communication skills and attention to detail required.

· Experience with Microsoft Excel for spreadsheets, Microsoft Word for word processing and Computer-Aided Design (CAD) tools (including 3D modeling) required.

· Experience with manufacturing processes including injection molding, machining, and mechanical assembly required.

· Prefer related medical device development experience.