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SalarySr. Mechanical Design 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. Medical Design and Development/Production 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 various medical diagnostic products used mainly in gastroenterology.
- Provide engineering production support for current line of High-Resolution Manometry products. Must be able to help 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
- Demonstrated ability to take product design from concept to finished component drawings using SolidWorks.
- 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
- Develop and maintain controlled documentation including drawings, specifications, and procedures
- Other tasks as assigned
Technical Qualifications
- A B.S. in Mechanical Engineering with at least 10-15 years of industry experience as a mechanical engineer.
- Experience with biocompatible materials and adhesives is desired
- Knowledge and experience in engineering mechanics, electroMechanical Design, and material processing
- Knowledge and experience with design, fabrication and assembly of micro-miniature parts desired
- Knowledge and experience with fixture design
- Proficient with SolidWorks CAD software
- Proficient in Microsoft Word and Excel
- Experience with FDA, ISO, and EU MDR standards is desired
- Excellent technical writing skills
- Strong verbal and written communication skills
- Must possess strong problem solving, decision making, analytical and organizational skills.
- Take proactive role in working across functional areas (production, sales, marketing, materials management, etc.) to solve business related needs
Benefits
- Medical, dental, and vision insurance
- Employee Assistance Program
- Company paid life insurance
- 401k w/ company match
- Generous vacation
- Flexible 9/80 work schedule
- Paid holidays
