Position Description:

Provide coordination to cross functional groups to ensure software quality objectives are met for product software, manufacturing software, quality system software and software technologies included or used in the creation or production of medical devices. Coordinate Medical Device Product development and SDLC (Software Development Life Cycle) including complex government and industry regulations including FDA 21 CFR Parts 11 and 820, ISO 13485, ISO 14971, and IEC 62304. Understand and work with various programming languages. Utilize software packages to include Minitab. Define and implement software quality metrics to track software progress and quality throughout the development process, implement software risk and reliability tools including Software Failure Mode Effect Analysis (SW dFMEAs) and practices that effectively support software requirements for product software design, integration and verification, validation, and prediction. Review, analyze, and disposition Software Defects or Software Problem Reports (SPRs). Coordinate numerous software validation processes, Medical Device Design Controls, Design History File, and Product Life Cycle. Understand process of software validation, Test Methods Development, Automation testing, and Verification and Validation (V&V) of product software. Position works a hybrid model and will be onsite in Lafayette, CO location - 3 days per week. * Relocation assistance not available for this position. #LI-DNI.

Basic Qualifications:

Masters’ Degree in Computer Science, Software Engineering, Biomedical Engineering or related IT or engineering field and one (1) year of experience as a Software Quality Engineer or Software Engineer OR Bachelors’ Degree in Computer Science, Software Engineering, Biomedical Engineering or related IT or engineering field and two (2) years of experience as a Software Quality Engineer or Software Engineer. Must possess a minimum of one (1) year of experience with each of the following: FDA 21 CFR Parts 11 and 820, ISO 13485, ISO 14971, and IEC 62304; Defining and implementing software quality metrics; SW dFMEA; Product software requirements; Software Problem Reports or Software Defects; Medical Device Design Controls, Design History File, and SDLC; and Test Methods Development, Automation testing, and V&V of Product software.

Salary: $95,500 to $115,200 per year

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We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.

Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.

We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world

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These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

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Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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