About this opportunity
Diversatek Healthcare lists this Senior Mechanical Engineer opportunity in highlands ranch, Colorado. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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 looking to exercise their problem solving and intellectual curiosity. The successful candidate will participate in the development of products throughout the entire cycle, from inception to technical design, and through commercialization.
Responsibilities
Design, develop and document specific portions of medical diagnostic products used in gastroenterology.
Provide engineering production support for the current line of diagnostic products.
Proactively troubleshoot complex production related issues and work to improve manufacturability and durability.
Develop and improve designs, processes and fixturing as needed to support the High-Resolution Manometry product line
Test and evaluate product concepts and/or final models for functionality, as well as their ability to meet the product specifications, write test plans, execute and document test processes
Research new materials and manufacturing processes to improve product quality and/or reduce costs
Support product verification effort as required to qualify and release medical diagnostic devices.
Spearhead vendor selection and assist in problem resolution.
Perform investigations on failure analysis and recommend corrective actions
Help ensure product development activities comply with FDA, ISO, and EU MDR standards
Create and maintain controlled documentation including drawings, specifications and procedures
Proactively work across functional areas (production, sales, marketing, materials management, etc.) to solve business related needs
Other tasks as assigned
Technical Qualifications
B.S. in Mechanical Engineering or equivalent.
8-15 years of relevant industry experience as a mechanical engineer.
Experienced with biocompatible materials and adhesives.
Knowledge and experience in engineering mechanics, electromechanical design, and material processing
Knowledge and experience with production fixture design
Proficient with SolidWorks CAD software
Proficient with Microsoft Word and Excel
Experience with FDA, CE Mark, and ISO, and EU MDR standards is desired
Excellent technical writing skills
Strong verbal and written communication skills
Must possess exceptional attention to detail required for medical product design
Must possess strong problem solving, decision making, analytical and organizational skills.
Preferred Qualifications
Experienced with circuit design and troubleshooting
Experienced with flexible circuit design
Knowledge and experience with design, fabrication and assembly of micro-miniature parts
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.