Software Quality Engineer I
About The Position
Medtronic is seeking a Software Quality Engineer I to support the quality of design, development, and maintenance of software for Affera cardiac electrophysiology systems. The role works with engineers and cross-functional partners to support software quality and regulatory compliance for Cardiac Ablation Solutions products and Affera software releases. It combines quality, compliance, and technical work intended to support product reliability, security, and patient outcomes. The position supports software risk analysis, post-market activities, review and approval of software and security design-history documentation, quality metrics, and product security testing. The engineer develops product and project expertise through training and hands-on work in the engineering lab, and collaborates with R&D, medical safety, regulatory affairs, and clinical teams. The role is onsite at least four days per week, with travel of less than 10%, and is not eligible for immigration sponsorship.
Requirements
- Bachelor's degree.
- Ability to write new software code and quickly and effectively read, interpret, and understand existing software code in order to collaborate with software engineers and execute necessary work.
Nice To Haves
- Excellent written and oral communication skills.
- Experience in the medical-device or another regulated industry, such as defense or aerospace, and/or 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 in regulated environments, including design, development, and post-market support.
- Experience with cardiac or electrophysiology medical specialties.
- Advanced degree in a relevant field.
Responsibilities
- Support software quality efforts for Cardiac Ablation Solutions products and ensure compliance with applicable regulatory standards, including FDA CFR, MDR, IEC 62304, and ISO 13485.
- Serve as a member of the extended quality team for Affera software releases used in electrophysiology procedures.
- Complete assigned functional work in collaboration with quality team members and within program deadlines.
- Participate in software risk analysis to help ensure comprehensive software risk-file coverage.
- Provide assigned software quality support for post-market activities and analysis, including defect assessments, issue assessments, health risk assessments, and CAPAs.
- Review and approve software- and security-related Design History File documents, including requirements, design, development, integration, test protocols, test reports, verification, validation, and tooling.
- Ensure documentation meets reliability standards and follows quality management system processes.
- Develop and review documentation for traceability, testability, and compliance with standard operating procedures.
- Develop expertise in assigned products and projects through engineering-lab work and assigned product training.
- Contribute to tracking software quality metrics and support continuous monitoring and improvement of quality outcomes and product reliability.
- Recommend design or test methods to achieve appropriate product reliability and security.
- Propose design or testing changes as needed to improve software or process reliability.
- Contribute to quality engineering program strategies that support Medtronic, customer, and regulatory reliability objectives.
- Review and support assigned product security testing strategies.
- Attend a live electrophysiology case at least once per year when available and regularly participate in virtual live-case learning opportunities.
- Collaborate with R&D, medical safety, regulatory affairs, and clinical teams to align on quality and compliance requirements.
Benefits
- Competitive compensation and flexible benefits package.
- Short-term incentive through the Medtronic Incentive Plan (MIP).
- Health insurance.
- Dental insurance.
- Vision insurance.
- Health Savings Account.
- Healthcare Flexible Spending Account.
- Life insurance.
- Long-term disability leave.
- Dependent daycare spending account.
- Tuition assistance or reimbursement.
- Global well-being program (Simple Steps).
- Incentive plans.
- 401(k) plan with 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.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
