Senior DA Engineer, growing medical device start-up.
Overview.
Support Design Verification and Design Validation testing and associated methods.
Lead or support corrective and preventive actions to continuously improve our designs and test methods.
Lead or support Design Controls process and Design Reviews process.
Support compiling technical documentation in relation to regulatory submissions.
Support the development of test methods and associated work instructions as required Support Human Factors and Usability studies.
Ensure smooth transition of activities from design to manufacturing e.g.
transition of dFMEA to pFMEA, transition of Design Specifications to Manufacturing Specifications, transition of Design Test Methods to Process Test Methods, etc.
Work with existing and future external design\manufacturing partners and suppliers.
Qualification:
Engineering, scientific or technical degree (ASQ CQE accepted) .
Experience: 3 years+ engineering experience in Design Assurance or R&D.
Within an ISO 13485 QMS or equivalent environment.
Strong experience of design controls and design reviews and design change processes.
Strong experience in use FMEA and\or design FMEA.
Strong experience in problem solving & root cause investigations.
Use of statistical tools.
Proficient in MS Excel & MS Word.
Advantageous to Have:
Process or test equipment validation experience.
Previous experience working in a startup or SME environment.
Optimising processes with a view to Design for Manufacturability (DFM).
Validating test methods and test equipment or test software.
Strong background in the use of statistical methods.
Experience working with sterile devices.
Experience working with electro-mechanical equipment or devices containing software.
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For more info see Skills:
R&D Medical Device Quality Engineering Design Assurance