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Component Qualification Engineer

4 months ago

Santa Clara, United States Diverse Lynx Full time
Job Title: Component Qualification Engineer
Location: Santa Clara, CA
Duration: Fulltime

Job Description : Job Title Component Qualification Engineer Relevant Experience
(in Yrs) 8+ Years Must Have Technical/Functional Skills Experience in development of medical device components, building the device assemblies and instruments.
Change control in a regulated environment (preferably medical device)
Manufacturing and process development experience
Statistical process control / capability analysis
Measurement system analysis, including GR&R
Risk analysis, including use of FME
Engineering drawing interpretation including GD&T fundamentals
Know- how about Product Life Cycle Management Experience Required Must have experience in the medical devices industry as well as a basic understanding of the regulatory requirements
Must have experience in Engineering Documentation for medical devices (Product Design & Development Documents, Protocols, Test Reports, MEMOs and Rationales for Engineering Activities)
Experience on equipment/ tool development and qualification
Knowledge of statistical analysis and its applicability to derive engineering rationale
Knowledge of change management plans

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.