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Search for Jobs by Jan Sather

Senior Mechanical Engineer (Science & Biotech)
golden, CO 80104
Recruited by: Jan Sather | Recruiter | Top Talent Search LLC See all my Jobs

  • Hiring Company: TopTalent Search
  • Industry: Science & Biotech
  • Compensation: Salary: 100K to 125K
  • Expires: Jul 08, 2021
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Interested?    Give us a call    303-961-6934

Job Description

The company has made some recent changes that give it the ability to pursue more projects and bigger projects. The key components including financing are now in place. Will guide how to provide mechanical engineering expertise from product prototype and development through commercialization. Will also learn how to provide product design guidance and consultation support on commercialized product. Good communication skills are important for client technical interface.

• Provide continuing product support for manufacturing, regulatory and quality on design requirements, customer needs, testing, CAPA, reliability predictions, and product documentation.
• Ensure compliance to the requirements of ISO 13485 standards, FDA regulations and Good Manufacturing Processes regarding design and development of new product designs and product upgrades.
• Support of the Engineering Change Order (ECO) process per Design Controls – Design Change regulations and internal policies
• Substantiate product design by developing test plans, performing design analysis, making design adjustments, running performance calculations, and maintaining quality standards.
• Other duties as assigned
• FDA Design Controls for medical devices. - Required
• Knowledge and experience with application of Six Sigma statistical analysis and controls. - Preferred
• Understanding and experience in product design and development including the use of tools such as WFD, FEA, Risk Analysis, DFMA, SUS and GT&T, DFMEA.
• Strong design and documentation skills using the Solidworks CAD application. - Required

• Bachelor in Mechanical Engineering or equivalent experience - Required
• Master in Mechanical Engineering - Preferred

• 8+ years of related design and development experience for medical device electromechanical components - Preferred
. • Will consider electromechanical products experience in the aerospace industry also
Interested?    Give us a call    303-961-6934