Sr. R&D Engineer

Job Role: Sr R&D Engineer

Location: Irvine, CA

Duration: 12+ Months

Job Description

Medical Device-New product development

will be responsible for design modifications and development activities of existing products including full product development cycle

Working knowledge of Technical files and Medical Device product development process,

Create or update Risk Management (DFMEA, PFMEA, AFMEA), DHF, and Tech File documentation

Write and review engineering test protocols for testing of component parts and integrated systems.

Design and develop new products, processes and methods, and design experiments using appropriate software tools and statistical methodology

Execute or supervise key technical project activities such as design verification testing, sterilization validation testing, cleaning and disinfection validation testing, reprocessing testing, ISO 10993 related biocompatibility testing, shelf life testing, packaging validation testing, and ISTA shipping validation testing.

Should have good communication skills to be able to communicate with steak holders, project managers, outside vendors,

Provide extensive engineering documentation with proper use of laboratory notebooks, spreadsheets and graphical summary of results in support of development, intellectual property applications, regulatory FDA filings, and verification and validation protocols.

Education / Experience Requirements

BS / MS in Mechanical Engineering with 6+ years of Experience in Medical Devices

Note: Please send the resumes to ravi@starkassociatesllc.com or contact +1 848-300-0022