Position Title: Systems Engineer
Location: Dublin, CA
Duration: 12 months
Ideal Start Date: ASAP - 07/29/2019
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 phone/Skype/Webex or go directly to onsite if local for 30-45 minutes. Second round will either be onsite or Skype/Webex for 1-2 hours with hiring manager and other team member.
Focus: Client needs a System Engineer to support new product development. Fast-paced R&D 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 R&D 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.
- 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
- Leading the R&D team through a rapid technical resolution of failures on devices at R&D testing and manufacturing final test
- 7-10 years product environment experience, preferably in Medical Device.
- Documentation experience
- Experience with test procedure for FRUs (field replaceable units)