Job Search Results for medical device regulations

{"JobID":422048,"JobType":["Contract"],"EmployerID":null,"Location":{"Latitude":-121.909818181818,"Longitude":37.3116363636364,"Distance":null},"State":"California","Zip":"95128","ReferenceID":"SJC-791640","PostedDate":"\/Date(1750965358000)\/","Description":"-Execute process validations (IQ/OQ/PQ), including protocol development and test reporting-Collaborate with NPI engineering teams to evaluate and prioritize critical test processes during design transfer-Develop and maintain automated test scripts for data collection and analysis-Support continuous improvement of test infrastructure and documentation to meet compliance and quality standardsWe are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 Human Resources Request Form. The EEOC \"Know Your Rights\" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .","Title":"Test Engineer","City":"San Jose","ExpirationDate":null,"PriorityOrder":0,"Requirements":"2+ years of experience in manufacturing test method validationStrong understanding of process qualification and validation (IQ/OQ/PQ)Background in the medical device industry, with solid understanding of regulatory standards (e.g., PFMEAs, IQ protocols, FDA compliance)Proficiency in Python and ideally the Pytest framework","Skills":"-Familiarity with regulatory standards and design for testability (DfT) principles-Electrical Engineering background-Experience with GIT, Agile PLM, MES Camstar-Experience with robotic systems","Industry":"Electrical Engineering","Country":"US","Division":"IT","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":68.0000,"SalaryLow":54.4000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}

{"JobID":418227,"JobType":["Contract-to-perm"],"EmployerID":null,"Location":{"Latitude":-117.197363636364,"Longitude":32.8517272727273,"Distance":null},"State":"California","Zip":"92122","ReferenceID":"SDG-786003","PostedDate":"\/Date(1748870150000)\/","Description":"A client in San Diego is looking for a Sr Systems Software Engineer to support the system configuration and modeling for the Illuminas Laboratory Information Management System (LIMS). This person will be responsible for ompiling relevant information related to product and process definition, analyzing business and compliance requirements, assessing risks for impact, and procuring accurate information for use in global systems. In addition to product configuration and change activities, tasks include support and iteration of LabVantage LIMS, management of Engineering Change Requests and Change Orders (ECRs/ECOs), workflow process development, and identification and participation in product and process improvements initiatives.- Own, Support, and iterate system development life cycle for LIMS to develop and optimize manufacturing process flows-Understanding of master data and the roles played by PLM, ERP, MES, LIMS, etc. in support of manufacturing and product release-Develop and maintain product and process configurations and collaborate on the implementation of solutions in LIMS, PLM and ERP. Candidate must have a solid understanding of LIMS/PLM/ERP and changes to downstream cross functional areas and systemsWe are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, 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 Human Resources Request Form. The EEOC \"Know Your Rights\" Poster is available here. To learn more about how we collect, keep, and process your private information, please review Insight Global\u0027s Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .","Title":"INTL - LabVantage Java Developer","City":"San Diego","ExpirationDate":null,"PriorityOrder":0,"Requirements":"Top hard skills-Java \u0026 groovy (software programming languages)-Lab vantage-Working in a regulated environment - working in a java code thy need documentation, need to used to working with documentation-Design documents, use the doc on how they validate the code they develop-Minimum 5 years of direct hands-on experience managing configuration change management in LIMS, LabVantage LIMS-Experience converting process flows into automated workflow models-Technical background in manufacturing, preferably in a life sciences, diagnostic, and/or medical device environment-Experience with LIMS applications like ERP, PLM, MES, SDMS, Instruments, etc.-PLM experience","Skills":"*Experience with Software Development Life Cycle of quality systems preferred-Experience with process and material change and configuration activities within an Enterprise Resource Planning (ERP) system, SAP preferred-Working knowledge of ISO 13485 and cGMP requirements desired","Industry":"Software Engineering","Country":"US","Division":"IT","Office":null,"IsRemoteJob":false,"IsInternalJob":false,"ExtraValues":null,"__RecordIndex":0,"__OrdinalPosition":0,"__Timestamp":0,"Status":null,"ApplicantCount":0,"SubmittalCount":0,"ApplicationToHireRatio":0,"JobDuration":null,"SalaryHigh":20.0000,"SalaryLow":16.0000,"PayRateOvertime":0,"PayRateStraight":0,"Filled":0,"RemainingOpenings":0,"TotalOpenings":0,"Visa":null,"ClearanceType":null,"IsClearanceRequired":false,"IsHealthcare":false,"IsRemote":false,"EndClient":null,"JobCreatedDate":"\/Date(-62135578800000)\/","JobModifiedDate":"\/Date(-62135578800000)\/"}