Software Design Control Engineer

As a Software Design Control Engineer, you will be responsible for creating and managing technical documentation to support projects efficiently while ensuring operational effectiveness. You will work closely within the Multiport software team and collaborate with cross-functional teams including NPD Design, Clinical, Human Factors, PMO, Quality, Regulatory, and Document Control teams. Key responsibilities include:Evaluating design changes, both software and hardware, introduced during product releases, and assessing their impacts on risks, requirements, and testing processes.Updating or generating risk traces, identifying gaps, and collaborating with various department as necessary to guarantee comprehensive test coverage.Guiding design decisions using documented product risk assessments and strategic design controls.Supporting documentation automation efforts by providing requirements and guidelines to develop appropriate tools and enhance their utilization.Developing, executing, maintaining, and supporting design control infrastructure, including risk analysis, Design Failure Modes and Effects Analysis (dFMEAs), and requirements documentation.These responsibilities are designed to ensure robust product development and high-quality standards throughout the project lifecycle.RequirementsBS degree in engineering discipline, or equivalent 5+ years industry experience Medical device experience Familiarity with design controls risks, trace reports, design controls Strong writing and grammar skills in areas of content development and writing style. Analytical ability to swiftly grasp and effectively communicate complex technical engineering concepts. Excellent written and verbal communication skills with a proven ability to present information in a clear and concise manner to various technical, business stakeholder, and leadership audiences Preferred QualificationsKnowledge of medical device regulations, both US and OUS (e.g., FDA regulations, MDR, China PTR, etc.). Experience working with design control software (MKS, Polarion, etc.)Terms and StartOnsite in Sunnyvale, CAFull time - 40hrs/weekBenefits included: Medical, Dental, Vision6-month contract, possibility to extend