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About the role
We anticipate the application window for this opening will close on - 22 Jul 2025
Design and deliver the medical device and supplies breakthroughs that make a difference in the lives of millions of patients.
Does this work inspire you?
Work with new product development teams to ensure that software used in the development, manufacture and as part of medical devices is developed and validated according to good design practices and requirements set forth by regulatory authorities. Help the development team by improving processes, through use of better tools, practices and automation, where applicable. Work with early technology teams to develop test strategies, methodologies and tools, where necessary.
What is the work you will be doing?
Responsible for the quality of software products in the HealthCast portfolio.
Learn the medical device industry requirements for quality systems, security, and software development and validation. Provide guidance to teams to ensure that these requirements are met.
Create risk management plans, perform product risk assessment, facilitate the failure mode effects analysis, and create final risk management reports.
Generate strategies for measuring software reliability and security, develop metrics and evaluate results.
Contribute to process improvements by identifying and validating better design tools, developing test strategies, methodologies and tools, where necessary.
Participate in review of requirements, architecture, design, code and other work products with a focus on patient safety and device quality, testability, manufacturability, serviceability and security.
Provide oversight of product software verification and manufacturing software validation processes.
Oversee problem-tracking process and defect process resolution.
Support outsourced software vendor audits and qualification, as required.
Ensure that new product development and changes to existing products are conducted in compliance with the FDA Quality System Regulations and Medtronic internal processes.
Learn statistical analysis techniques for determining sample size and analyzing test results. Provide guidance to teams to ensure that statistically relevant and appropriate verification and validation testing is planned and completed.
Review Design History Files and Technical Files for conformance to applicable requirements.
Assist, when appropriate with internal, external, and supplier audits.
Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.
Understanding of software programming techniques
Ability to review and understand system and software architectural designs
Good verbal (including presentation) and written communication skills
Ability to effectively work on project teams.
Nice to Have
Bachelor of Science degree in Computer Science, Computer Engineering or Electrical Engineering
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Software Quality Engineer for the HealthCast franchise in Acute Care and Monitoring focusing on new product development.Design and deliver the medical device and supplies breakthroughs that make a difference in the lives of millions of patients.
Does this work inspire you?
Work with new product development teams to ensure that software used in the development, manufacture and as part of medical devices is developed and validated according to good design practices and requirements set forth by regulatory authorities. Help the development team by improving processes, through use of better tools, practices and automation, where applicable. Work with early technology teams to develop test strategies, methodologies and tools, where necessary.
What is the work you will be doing?
Responsible for the quality of software products in the HealthCast portfolio.
Learn the medical device industry requirements for quality systems, security, and software development and validation. Provide guidance to teams to ensure that these requirements are met.
Create risk management plans, perform product risk assessment, facilitate the failure mode effects analysis, and create final risk management reports.
Generate strategies for measuring software reliability and security, develop metrics and evaluate results.
Contribute to process improvements by identifying and validating better design tools, developing test strategies, methodologies and tools, where necessary.
Participate in review of requirements, architecture, design, code and other work products with a focus on patient safety and device quality, testability, manufacturability, serviceability and security.
Provide oversight of product software verification and manufacturing software validation processes.
Oversee problem-tracking process and defect process resolution.
Support outsourced software vendor audits and qualification, as required.
Ensure that new product development and changes to existing products are conducted in compliance with the FDA Quality System Regulations and Medtronic internal processes.
Learn statistical analysis techniques for determining sample size and analyzing test results. Provide guidance to teams to ensure that statistically relevant and appropriate verification and validation testing is planned and completed.
Review Design History Files and Technical Files for conformance to applicable requirements.
Assist, when appropriate with internal, external, and supplier audits.
Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.
Understanding of software programming techniques
Ability to review and understand system and software architectural designs
Good verbal (including presentation) and written communication skills
Ability to effectively work on project teams.
Nice to Have
Bachelor of Science degree in Computer Science, Computer Engineering or Electrical Engineering
Responsibilities may include the following and other duties may be assigned.
- Develops, modifies, applies, and maintains standards for software systems quality operating methods, processes, and procedures.
- Conducts evaluation of software systems activities including requirements, design, development, documentation, integration, test, verification and validation.
- Defines appropriate measures to ensure product quality.
- Develops overall operating criteria to ensure implementation of the software quality program according to project, process and contract requirements and objectives.
- Ensures that projects and process control documentation are compliant with requirements, objectives and/or contracts.
- Reviews software systems design, change specifications, and plans against contractual and/or process requirements.
- Reviews include applicable specifications, materials, tools, techniques, and methodologies.
- Provides or directs verification and validation of software system requirements, traceability, and testability.
TECHNICAL SPECIALIST CAREER STREAM: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desi
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