Senior Mechanical Engineer - Medical Devices, Full Cycle

Diversatek Healthcare, Inc.; Highlands Ranch (CO); On-site; USD 110,000 - 150,000; Full time

Job summary

Diversatek Healthcare, Inc. in Highlands Ranch, CO is seeking a Sr. Mechanical Engineer to design, develop and document components of medical diagnostic products from concept through commercialization.

You will provide production support, troubleshoot manufacturing issues, improve fixture design, and ensure compliance with FDA, CE and EU MDR standards while collaborating with cross-functional teams.

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.

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

Skills

Attention to detail

Problem solving

Strong communication

Analytical skills

Technical writing

Education

B.S. in Mechanical Engineering or equivalent

Tools

SolidWorks CAD

Microsoft Word

Microsoft Excel

Job description

Diversatek Healthcare, Inc. in Highlands Ranch, CO is seeking a Sr. Mechanical Engineer to design, develop and document components of medical diagnostic products from concept through commercialization.

You will provide production support, troubleshoot manufacturing issues, improve fixture design, and ensure compliance with FDA, CE and EU MDR standards while collaborating with cross-functional teams.