Planet Pharma
Software Reliability/Design Assurance Engineer (Junior Level) - Medical Devices
Planet Pharma, Minneapolis, Minnesota, United States, 55400
Overview
Software Reliability/Design Assurance Engineer (Junior Level) - Medical Devices Our client, a leading Medical Device company, is seeking a Software Reliability & Design Assurance Engineer for their growing team. The ideal candidate will have 1-3 years of experience working within a regulated industry doing reliability testing and designing FMEAs for software products. Responsibilities
Design assurance or software product design activities Lead and facilitate design FMEAs and assist with GSPR Hands-on reliability testing in the lab, including setup, registration of product/device, and triggering manual transmissions Technical writing Conduct software reliability testing and software reliability FMEA for cloud software products Apply risk management (ISO 14971) and hazard/risk analysis techniques (PHA, HA, FTA, DFMEA) Use Software Reliability Engineering models including growth models Lead investigations to identify system/product failures, hazards, hazardous situations, and harms Design, maintenance, or continuation engineering of released software or software systems (including mobile apps) Experience with automated and/or manual software tests Work with Agile or behavior-based development Compliance with medical device regulations (e.g., 21 CFR Part 820, ISO 13485, IEC 62304) Knowledge of DFSS, Design for Lean Sigma (DFLS), Design for Reliability and Manufacturability (DRM), or other robust design practices Apply statistics using tools such as Minitab Develop reliability studies, DOE concepts, and evaluate engineering design concepts Recommend design or test methods and SPC procedures to achieve reliability goals Complete risk analyses for new designs and processes Analyze performance data and identify variables affecting product quality Ensure corrective actions meet reliability standards Qualifications
1-3 years hands-on experience in software QA within a regulated industry Bachelor\'s degree in Engineering GDP and technical writing skills Experience with Design for Six Sigma, Design for Lean Sigma, or robust design practices is a plus Experience with IEC 62304, ISO 13485, and 21 CFR Part 820 Experience with Minitab and statistics Experience with cloud software products and released software systems Experience in medical devices or other regulated industries Employment type
Contract Industries
Biotechnology, Research and Medical Equipment Manufacturing
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Software Reliability/Design Assurance Engineer (Junior Level) - Medical Devices Our client, a leading Medical Device company, is seeking a Software Reliability & Design Assurance Engineer for their growing team. The ideal candidate will have 1-3 years of experience working within a regulated industry doing reliability testing and designing FMEAs for software products. Responsibilities
Design assurance or software product design activities Lead and facilitate design FMEAs and assist with GSPR Hands-on reliability testing in the lab, including setup, registration of product/device, and triggering manual transmissions Technical writing Conduct software reliability testing and software reliability FMEA for cloud software products Apply risk management (ISO 14971) and hazard/risk analysis techniques (PHA, HA, FTA, DFMEA) Use Software Reliability Engineering models including growth models Lead investigations to identify system/product failures, hazards, hazardous situations, and harms Design, maintenance, or continuation engineering of released software or software systems (including mobile apps) Experience with automated and/or manual software tests Work with Agile or behavior-based development Compliance with medical device regulations (e.g., 21 CFR Part 820, ISO 13485, IEC 62304) Knowledge of DFSS, Design for Lean Sigma (DFLS), Design for Reliability and Manufacturability (DRM), or other robust design practices Apply statistics using tools such as Minitab Develop reliability studies, DOE concepts, and evaluate engineering design concepts Recommend design or test methods and SPC procedures to achieve reliability goals Complete risk analyses for new designs and processes Analyze performance data and identify variables affecting product quality Ensure corrective actions meet reliability standards Qualifications
1-3 years hands-on experience in software QA within a regulated industry Bachelor\'s degree in Engineering GDP and technical writing skills Experience with Design for Six Sigma, Design for Lean Sigma, or robust design practices is a plus Experience with IEC 62304, ISO 13485, and 21 CFR Part 820 Experience with Minitab and statistics Experience with cloud software products and released software systems Experience in medical devices or other regulated industries Employment type
Contract Industries
Biotechnology, Research and Medical Equipment Manufacturing
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