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Senior Mechanical Engineer jobs in United States
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Diversatek Healthcare · 4 hours ago

Senior Mechanical Engineer

Diversatek Healthcare is a global, multi-platform healthcare solutions manufacturing company. They are seeking a Senior Mechanical Engineer to participate in the development of medical diagnostic products, focusing on design, troubleshooting, and compliance with industry standards.
3D PrintingMedical DeviceHealthcareHealth CareMedical
Hiring Manager
Hannah Lipscomb
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Responsibilities

Design, develop and document specific portions of medical diagnostic products used in gastroenterology
Provide engineering production support for the current line of High-Resolution Manometry 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

Qualification

Mechanical EngineeringSolidWorksBiocompatible materialsFDA standardsCircuit designTechnical writingProblem solvingCommunication skills

Required

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

Experienced with circuit design and troubleshooting
Experienced with flexible circuit design
Knowledge and experience with design, fabrication and assembly of micro-miniature parts

Benefits

Medical, dental, and vision insurance
Employee Assistance Program
Company paid life insurance
401k w/ company match
Generous PTO
Flexible 9/80 work schedule
Paid holidays

Company

Diversatek Healthcare

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Diversatek Healthcare focus on smart solutions for medical diagnostics and therapeutics procedures.

Funding

Current Stage
Growth Stage

Leadership Team

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Meg Vierling
President and CEO
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Company data provided by crunchbase