Senior Mechanical Engineer

Diversatek Healthcare; Highlands Ranch (CO); On-site; USD 110,000 - 160,000; Full time

Job summary

Diversatek, Inc. in Highlands Ranch, CO is seeking a Sr. Mechanical Engineer to design, analyze and document medical diagnostic products for gastroenterology, from concept through commercialization.

Bring 8–15 years of mechanical engineering experience and a track record in biomedical devices. The role requires SolidWorks proficiency, strong communication, attention to detail, and familiarity with FDA, CE and ISO/EU MDR standards.

Qualifications

• B.S. in Mechanical Engineering or equivalent.
• 8-15 years of relevant industry experience as a mechanical engineer.
• Experience 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, 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.

Responsibilities

• Design, develop and document portions of medical diagnostic products used in gastroenterology.
• Provide engineering production support for current product lines.
• Troubleshoot production-related issues and improve manufacturability and durability.
• Develop and improve designs, processes, and fixturing for HP/High-Resolution Manometry line.
• Test and evaluate concepts and final models; write and execute test plans.
• Research materials and manufacturing processes to improve quality or reduce costs.
• Support product verification to qualify and release devices.
• Lead vendor selection and assist in problem resolution.
• Investigate failures and recommend corrective actions.
• Ensure development activities comply with FDA, ISO, and EU MDR standards.
• Create and maintain controlled documentation including drawings, specifications and procedures.
• Collaborate across production, sales, marketing, and materials management.

Skills

Problem solving

Attention to detail

Verbal and written communication

Engineering mechanics

Electromechanical design

Material processing

Education

B.S. Mechanical Engineering

Tools

SolidWorks

Microsoft Word

Microsoft Excel

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