Senior Mechanical Engineer - Medical Devices & Diagnostics

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

Job summary

Diversatek, Inc. is a global healthcare solutions manufacturer seeking a Sr. Mechanical Engineer to contribute across the product development lifecycle from inception to commercialization.

You will design, document, test and optimize medical diagnostic products used in gastroenterology, while ensuring compliance with relevant standards and collaborating with cross-functional teams. The role emphasizes problem solving, attention to detail and strong technical writing, with exposure to

Qualifications

• B.S. in Mechanical Engineering or equivalent.
• 8-15 years mechanical engineering experience.
• Experience with biocompatible materials and adhesives.
• Knowledge of engineering mechanics and electro-mechanical design.
• Experience with production fixture design.
• FDA/CE/ISO/EU MDR standards experience is desired.
• Excellent technical writing and communication skills.
• Attention to detail and analytical skills.

Responsibilities

• Design, develop and document portions of medical diagnostic products.
• Provide engineering production support for current product line.
• Troubleshoot production issues and improve manufacturability and durability.
• Develop designs, processes and fixturing for High-Resolution Manometry.
• Test concepts and final models; write tests and document results.
• Research materials and processes to improve quality and reduce costs.
• Support product verification and release of devices.
• Spearhead vendor selection and resolve issues.
• Investigate failures and recommend corrective actions.
• Ensure compliance with FDA, ISO, EU MDR standards.
• Create controlled drawings, specifications and procedures.
• Collaborate across production, sales, marketing and materials.
• Other tasks as assigned.

Skills

Biocompatible materials knowledge

Strong problem solving

Attention to detail

Technical writing

Verbal and written communication

Education

B.S. in Mechanical Engineering

Tools

SolidWorks CAD

Microsoft Word

Microsoft Excel

Job description

Diversatek, Inc. is a global healthcare solutions manufacturer seeking a Sr. Mechanical Engineer to contribute across the product development lifecycle from inception to commercialization.

You will design, document, test and optimize medical diagnostic products used in gastroenterology, while ensuring compliance with relevant standards and collaborating with cross-functional teams. The role emphasizes problem solving, attention to detail and strong technical writing, with exposure to