R&D Engineer Sr. (Software Quality Assurance/ Software Testing)

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Nikhil Jhajharia at email address Nikhil.Jhajharia@generistek.com can be reached on # (630) 576-1935.We have Contract role R&D Engineer Sr. (Software Quality Assurance/ Software Testing) for client at Alameda, CA. Please let me know if you or any of your friends would be interested in this position.Position Details:R&D Engineer Sr. (Software Quality Assurance/ Software Testing)- Alameda, CALocation : Alameda, CA– 94502Project Duration : 12 Months of contractPay Rate : $81.00 per hour on W2Job Description:Participates as a member of the Software Quality Assurance (SWQA) team for Client Diabetes Care products that ensures digital applications produced by ADC is developed, validated, and maintained in compliance with regulatory, corporate and divisional requirements. Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software. Coordinate activities with other engineering disciplines, departments, and contractors.Duties:Completes software quality tasks in accordance with current Quality System Requirements.Works independently with objectives given by SWQA Manager.Can plan and coordinate own work according to higher-level project schedules.Reviews deliverables/activities as identified in the ADC Design Control Process/project plan or equivalent project plan. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports for the Alameda site.Ensures unexpected events, issues or software bugs which occur during verification/validation are addressed and/or processed under relevant design control and defect management procedures.Ensures compliance to relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11 and Client Diabetes Care requirements as they relate to the development, verification, validation, and maintenance of medical device software.Qualifications:Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.2 to 5 years’ experience in Software Quality Assurance and/or Software Testing experience.Knowledge of FDA QSR, relevant ISO guidelines and 21 CFR Part 11. Has knowledge of Design Control requirements.Must have 1 - 3 years project experience in software quality assurance practices, methodologies including Agile and techniques, preferably in medical device software such as web and mobile applications.Must have excellent oral and written communication skills.ASQ Certifications a plus.Medical Device experience strongly preferred.Cybersecurity, medical web and mobile applications or AI experience preferred. Role Context:Why is this role open? Need quality support for in development software projectWhat projects will this person support? Web and mobile applications (medical device software)What does a typical day look like? Agile team meeting, design document reviews, test analysis, software requirements review, R&D cross-functional interactions (e.g. systems, test, security)How would you roughly break down the work in percentages (e.g., project work, meetings, documentation, other)? 25% meetings, 25% project work, 35% documentation, 15% other)Who will they interact with regularly? R&D teams (Systems Engr, Test, Dev team, product manager, SWQA team)What does success look like in the first 90 days? Timely support of R&D teams to ensure design controls are implemented (e.g. approving software requirements, approving test cases, test plans, etc.)Have you interviewed for this role before? If so, what challenges did you face? Yes, qualified candidates have broad design control experience (e.g. risk management, requirements analysis, test planning, defect management). Skills & ExperienceTop 3 REQUIRED Skills (all required skills are non-negotiable unless explicitly noted):Required SkillTool / Technology / SystemDepth of Experience (Basic / Intermediate / Advanced)What the candidate must be able to doDesign controls in a regulated product environmentAgile methodologiesAdvancedChange impact analysisWeb and mobile medical device applicationsSoftware as a medical deviceIntermediateTechnical understanding of software applications, including APIsRisk managementISO14971IntermediateEnsure risk is addressed at all stages of software developmentEvaluate risk impact for software defectsIf applicable, indicate whether there is one specific required skill where flexibility may apply for a very strong candidate: Top 3 PREFERRED Skills:Preferred SkillTool / Technology / SystemValue to the Role (Nice-to-have vs Strong Advantage)Willing to Flex? (Yes / No)Atlassian Suite (Jira, Confluence)Atlassian toolsNice-to-haveYesTest Analysisn/aStrong advantageNoRequirements analysisn/aStrong advantagenoTo discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Nikhil Jhajharia at email address Nikhil.Jhajharia@generistek.com can be reached on # (630) 576-1935.