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
- 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.
Nice To Haves
- 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
