Planet Pharma
Principal Software Quality Engineer
Planet Pharma, Saint Paul, Minnesota, United States, 55130
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Location:
Mounds View, MN (strong preference for onsite 4 days/week) Top 3 Required Skill Sets: Experience with cardiac imaging data analysis Ability to distill software requirements from system requirements Strong communication skills with a variety of audiences including programmers, marketers, physicians, and business leaders Top 3 Day-to-Day Activities: Lead as a quality extended team member responsible for driving quality into software solutions in accordance with IEC 62304, IEC 82304-1 (SiMD and SaMD), FDA QSR (Quality System Regulation), and other global regulatory agency requirements Lead quality-focused design and development of software within the software development lifecycle by defining the requirements, design, verification and validation plan and strategies while maintaining traceability Develop test strategies, review test designs, and validate test scripts, verification of software for Transcatheter Valve Implant Sizing application, including cybersecurity requirements Responsibilities may include the following and other duties may be assigned: Lead as a quality extended team member responsible for driving quality into software solutions in accordance with IEC 62304, IEC 82304-1 (SiMD and SaMD), FDA QSR (Quality System Regulation), and other global regulatory agencies requirements Lead quality-focused design and development of software within the software development lifecycle by defining the requirements, design, verification and validation plan and strategies while maintaining traceability Develop test strategies, review test designs, and validate test scripts, verification of software for Transcatheter Valve Implant Sizing application, including cybersecurity requirements Develop, document, and test software to ensure that the software meets the needs of end-users and achieves business goals Develop and validate software-related scripts using Python / MATLAB for Finite Element Analysis, clinical imaging, Structural Integrity (Fatigue) testing and other design modeling applications Lead and conduct risk management activities including system risk analysis (ISO14971) and software risk management documentation, including system level risk management reviews, Failure Mode and Effects Analysis, product risk assessments and assessing specific product issues for impact to patient and/or user safety Provide Software (SW) risk management technical leadership to Design Quality Engineering peers Lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as ISO13485/IEC62304/IEC82304-1/HIPAA/FDA/Security Standards/Cybersecurity/Data Privacy) Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review reports, test results, verification and validation reports Review software systems design, change specifications, and plans against contractual and/or process requirements Provide guidance, coaching and training to other employees within job area Seniority level
Seniority level
Not Applicable Employment type
Employment type
Contract Job function
Job function
Engineering, Quality Assurance, and Information Technology Industries
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research Referrals increase your chances of interviewing at Planet Pharma by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for Software Quality Engineer roles.
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Mounds View, MN (strong preference for onsite 4 days/week) Top 3 Required Skill Sets: Experience with cardiac imaging data analysis Ability to distill software requirements from system requirements Strong communication skills with a variety of audiences including programmers, marketers, physicians, and business leaders Top 3 Day-to-Day Activities: Lead as a quality extended team member responsible for driving quality into software solutions in accordance with IEC 62304, IEC 82304-1 (SiMD and SaMD), FDA QSR (Quality System Regulation), and other global regulatory agency requirements Lead quality-focused design and development of software within the software development lifecycle by defining the requirements, design, verification and validation plan and strategies while maintaining traceability Develop test strategies, review test designs, and validate test scripts, verification of software for Transcatheter Valve Implant Sizing application, including cybersecurity requirements Responsibilities may include the following and other duties may be assigned: Lead as a quality extended team member responsible for driving quality into software solutions in accordance with IEC 62304, IEC 82304-1 (SiMD and SaMD), FDA QSR (Quality System Regulation), and other global regulatory agencies requirements Lead quality-focused design and development of software within the software development lifecycle by defining the requirements, design, verification and validation plan and strategies while maintaining traceability Develop test strategies, review test designs, and validate test scripts, verification of software for Transcatheter Valve Implant Sizing application, including cybersecurity requirements Develop, document, and test software to ensure that the software meets the needs of end-users and achieves business goals Develop and validate software-related scripts using Python / MATLAB for Finite Element Analysis, clinical imaging, Structural Integrity (Fatigue) testing and other design modeling applications Lead and conduct risk management activities including system risk analysis (ISO14971) and software risk management documentation, including system level risk management reviews, Failure Mode and Effects Analysis, product risk assessments and assessing specific product issues for impact to patient and/or user safety Provide Software (SW) risk management technical leadership to Design Quality Engineering peers Lead quality improvement projects to include compliance standards for software quality operating methods, processes, and procedures (such as ISO13485/IEC62304/IEC82304-1/HIPAA/FDA/Security Standards/Cybersecurity/Data Privacy) Participate in design reviews for the system as well as review and approve design input/design output artifacts including requirements, design documents, code review reports, test results, verification and validation reports Review software systems design, change specifications, and plans against contractual and/or process requirements Provide guidance, coaching and training to other employees within job area Seniority level
Seniority level
Not Applicable Employment type
Employment type
Contract Job function
Job function
Engineering, Quality Assurance, and Information Technology Industries
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research Referrals increase your chances of interviewing at Planet Pharma by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified when a new job is posted. Sign in to set job alerts for Software Quality Engineer roles.
Minneapolis, MN $100,000.00-$120,000.00 3 days ago Minneapolis, MN $100,000.00-$115,000.00 5 days ago Minneapolis, MN $100,000.00-$110,000.00 1 week ago Minneapolis, MN $70,000.00-$150,000.00 2 weeks ago Minneapolis, MN $80,000.00-$90,000.00 2 weeks ago Minneapolis, MN $65,000.00-$115,000.00 1 month ago Director of Software Engineering Quality
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Minneapolis, MN $60,000.00-$95,000.00 2 weeks ago Fridley, MN $80,000.00-$92,000.00 2 weeks ago Principal Engineer Supplier Quality - R10200899
Plymouth, MN $95,800.00-$143,600.00 6 days ago Senior Software Design Assurance Engineer
Eden Prairie, MN $100,000.00-$130,000.00 5 days ago Senior Software Test Engineer - Embedded Systems
Principal Test System Software Engineer (SDET)
Minneapolis, MN $150,000.00-$240,000.00 2 weeks ago Senior Systems Software Engineer - Jet Engine Test Cells
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Minneapolis, MN $141,000.00-$211,400.00 2 weeks ago Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr