A client in the Medical Device industry is seeking a Research + Development engineer to support integration activities for their recent acquisition. The ideal candidate will be a self starter who can demonstrate problem solving and project management skills to complete tasks under limited supervision. This resource will support all aspects of the Design History File by developing new requirements, validating new test methods, creating risk documentation, and performing applicable testing. They will understand and comply with all applicable regulatory requirements to maintain product safety + compliance. This role will be hybrid minimum 3 days/week in Valencia, CA with 10% travel expectations and will be a 12-14 month contract.
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
HR@insightglobal.com.
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* BS Degree in Computer Science, Software/Electrical Engineering, or related technical field
* 5+ years of related work experience OR applicable higher education (MS/PhD)
* 2+ years of experience with Design Controls and/or Process Validation
* Experience working within highly regulated medical field
o Specifically with FDA Quality System Regulations + ISO 13485
* Well versed in design verification, validations activities, test method development, and root cause analysis.
* Working knowledge of MiniTab and SolidWorks
* 3+ years of ElectroMechanical Engineering experience
* Prior experience leading projects driving design + process changes
* Knowledge of manufacturing processes + materials (silicone molding, laser welding, electronic component assembly, testing + packaging, etc.)
* SAP and Windchill experience
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.