Design Engineer II

Summary

Responsible for design and project management in the area of new product development, focusing on line extensions and new innovation products.

Essential Duties And Responsibilities

• Designs, develops, and maintains products within and outside of existing product lines.
• Generates and approves product development documentation on assigned projects.
• Shows advanced knowledge of CAD systems and makes decisions on intermediate technical matters related to product design.
• Investigates new materials and manufacturing techniques.
• 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.
• Generates quality systems and project related documentation as needed (e.g., DHF documents, work orders, charters).
• Understands and follows engineering related and overall company processes.
• Experience with following processes of ISO 9001 preferred, with experience in ISO 13485, ISO 14971, FDA, and MHLW requirements.
• Attends all relevant training and keeps abreast of relevant developments in technology.
• Participates in clinical evaluations.

Qualifications

• Minimum of a Bachelor's degree (BS) in engineering from a four-year college or university; five or more years of related experience; or equivalent combination of education and experience required.
• Demonstrates design, documentation, materials management, design for manufacturing, process management, and troubleshooting/problem-solving skills.
• Demonstrates interpersonal, organizational, and time management skills.
• Demonstrates good communication and attention to detail skills.
• Experience with Microsoft Excel for spreadsheets, Microsoft Word for word processing, and Computer-Aided Design (CAD) tools (including 3D modeling).
• Experience with manufacturing processes including injection molding, machining, and mechanical assembly.
• Preferred related medical device development experience.

Physical Demands

• Frequently sits, reaches with hands and arms, talks, and hears.
• Frequently uses hands to finger, handle, or feel.
• Sometimes stands, walks, climbs, balances, stoops, kneels, crouches, or crawls.
• Occasionally lifts and/or moves up to 50 pounds.
• Requires close vision, color vision, depth perception, and ability to adjust focus.

Work Environment

• Frequent exposure to moving mechanical parts.
• Occasional exposure to toxic or caustic chemicals and risk of electrical shock.
• Moderate noise level in the work environment.