Essential Duties and Responsibilities include the following. (Other duties may be assigned.)
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 introductory knowledge of the CAD system(s). Able to make decisions on simple technical matters related to product design.
Project Management:Able to plan, schedule, and manage multiple small product development and/or continuation engineering projects simultaneously. Communicates with OEMs, product line management 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. 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 Skills and Abilities
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 skills and attention to detail
Experience with Microsoft Excel for spreadsheets, Microsoft Word for word processing and Computer-Aided Design (CAD) tools (Solidworks Preferred).
Experience with manufacturing processes including injection molding, machining, and mechanical assembly
Prefer related medical device development experience.
Education and/or Experience
Minimum of a Bachelor's degree (BS) in engineering from a four year college or university; and one to two years related experience and/or training; or equivalent combination of education and experience.