2 jobs found

Duties and Responsibilities : Support the engineering team in development of new catheter-based medical devices and improvement of manufacturing processes in accordance with FDA and international regulations. • Support day-to-day engineering activities including hands on laboratory and manufacturing support. • Assemble medical device prototypes for product evaluation and testing. • Perform testing using standard laboratory and inspection equipment (e.g. force testers, calipers, flow models, gauges, etc.) • Build tools and fixtures utilizing experience with common shop tools. • Support installation, troubleshooting, and maintenance of R&D equipment. • Execute work according to approved procedures and provide feedback to update or generate new procedures as needed. • Ensure that product development and manufacturing activities are performed in accordance with U.S. Quality System Regulations (21 CFR 820) and ISO 13485 requirements. • Assure individual and group safety when...

Description Sr. Mechanical Engineer Highlands Ranch, CO About Our Company Diversatek, Inc. is a global, multi-platform healthcare solutions manufacturing company. Invested in a broad and ever-growing line of medical technologies, Diversatek manufactures and markets products and solutions for diagnostic and therapeutic gastroenterology procedures, continuing care and rehabilitation, and medical device OEMs. Diversatek owns and operates manufacturing facilities in Wisconsin, Colorado, and Ho Chi Minh City, Vietnam. Our Technical Research and Training Center in Highlands Ranch, CO boasts a best-in-class clinical education and product training center for healthcare providers worldwide. Description Are you an engineer who thrives on solving complex problems in the medical device industry? Do you often find you are most successful in a work environment that challenges your strong intellectual curiosity? We have an exciting opportunity for a Sr. Mechanical Engineer who is...