Software Quality Engineer I
About The Position
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. In this dynamic role, you’ll work alongside a team of engineers and cross-functional partners to drive quality for design, development, and maintenance of software for Affera cardiac electrophysiology systems. By blending technical expertise with a passion for quality, compliance, and improving patient outcomes, you'll have the opportunity to impact global healthcare as the usage of Affera grows rapidly worldwide.
Requirements
- Bachelor's degree and a minimum of 0 years of relevant experience
Nice To Haves
- Though this is not a coding role, the candidate must have proven ability to write new software code, and quickly and effectively read, interpret, and understand existing software code, to collaborate and execute necessary work with software engineers.
- Excellent written and oral communication skills.
- Medical device or other regulated industry (such as defense or aerospace) experience and/or industry experience working with a software development team.
- Experience performing formal risk analysis.
- Experience using or working with Python, Qt, Docker, and Linux.
- Knowledge of cybersecurity and the software lifecycle within regulated environments, including design, development, and post-market support.
- Experience with cardiac/electrophysiology medical specialties.
- Advanced degree in a relevant field.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Support software quality efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485.
- Serve as member of the extended quality team for Affera software releases used for electrophysiology procedures.
- Collaborate with other quality team members to take accountability for completing assigned functional work within program deadlines.
- Participate in software risk analysis activities to ensure comprehensive risk file coverage for software.
- Provide software quality support for post-market activities and analysis as assigned, including work supporting defect assessments, issue assessments, health risk assessments, and CAPAs.
- Review and approve various Design History File documents related to software and security, including requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling.
- Ensure all documentation meets reliability standards and follows QMS processes.
- Develop and review documentation for traceability, testability, and compliance according to standard operating procedures.
- Develop expertise in assigned products and projects, including hands-on time in the engineering lab and participation in product training as assigned.
- Contribute to tracking software quality metrics for assigned programs, supporting continuous monitoring and improvement of quality outcomes to achieve required levels of product reliability.
- Recommend design or test methods to achieve appropriate levels of product reliability and security.
- Propose changes to design or testing as necessary to improve software and/or process reliability.
- Contribute to quality engineering program strategies to achieve Medtronic, customer, and regulatory reliability objectives for assigned programs.
- Review and support strategies for product security testing as assigned.
- As available, attend a live EP case at least once per year to enhance workflow and product knowledge.
- Regularly participate in virtual live case learning opportunities.
- Collaborate with cross-functional teams, including R&D, medical safety, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
