Sr. R&D Engineer in Medical

Oxford Global Resources in Dublin, CA

  • Industry: Healthcare - Allied Health - Medical Technologist (MLS)
  • Type: Full Time
  • Compensation: $103,730.00 - 157,700.00 / Year*
position filled
Local Candidates preferred but will look at national candidates Position Title Sr. RD Engineer Location Dublin, CA Duration 12 months+ Ideal Start Date ASAP Position is 40 hours per week onsite NO REMOTE. Process First round interview with hiring manager - available as early as next week Thursday or Friday. Second round will take place following week (another team member involved in interviews returns June 24th). First round can be phoneSkypeWebex or go directly to onsite if local for 30-45 minutes. Second round will either be onsite or SkypeWebex for 1-2 hours with hiring manager and other team member. Focus Client needs a System Engineer to support new product development. Fast-paced RD environment and a very recently released product that they are updating with major features, essentially a 1.5 version of a pre-existing product. This engineer will be helping with tasks on the prior generation of the product and helping with sustaining and testing tool fixtures and modules, etc. Duties Candidate will be tasked with helping write test protocols, execute test protocols and documenting this work with test reports as they go. Main functions of the tests are to perform Risk Management and Product Safety for these ophthalmic medical devices. Must be fluent in the main compliance standard IEC 60601-1 for electrical safety. Key pieces of this role will be this IEC 60601-1 standard in particular, risk management files, and extensive documentation to ensure the products are safe to release to manufacturing. Emphasis on Test Compliance as opposed to Quality Compliance - prior candidate was very strong but was used to a much more stringent Government-regulated environment, whereas this is product development and RD with firm deadlines. Extra note Ideal candidate will be someone that is compiling the Compliance Checklist and creating the Risk Management Files - not someone that just performs System Verification where they are merely taking the OUTPUT. This candidate will be actually performing the analysis and creating the risk files, creating the checklist, showing the evidence, running the tests, investigating the issues, etc. Needs to really take charge on developing and leading the team on Verification Procedure, rather than just following the guidelines and taking the output. Necessary Requirements - IEC 60601-1 Standard experience - Risk Management and Product Safety for Medical Device Experience - again Risk Assessment Worksheets and Creating the Risk Management Files are crucial here - Compliance testing experience - creating the checklists and showing the evidence, making the verification procedure and not just performing the verification as outlined above - Hands-on Device-level testing (includes functional testing, system-level testing, and lab testing) - 50 of this job. Note Not just component level testing, but testing the whole system - Hands-on FMEA experience- this is very important - 7-10 years product environment experience, preferably in Medical Device. - Documentation experience Desired Experience - Experience with test procedure for FRUs (field replaceable units) - Leading the RD team through a rapid technical resolution of failures on devices at RD testing and manufacturing final test
Associated topics: bio, bioengineering, biomaterials, biophysics, bioprocess, biosynthetic, enzyme, msat, parenteral, pharmaceutical

* Estimated salary

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