Quality Engineer supporting product development and quality assurance at Evergen. Leading investigations, supporting supplier qualifications, and ensuring compliance with standards.
About the role
- Software Quality Engineer II at Medtronic driving quality for cardiac electrophysiology systems. Collaborating with engineering teams to ensure compliance with regulatory standards and improve patient outcomes.
Responsibilities
- Support software quality and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485
- Serve as a member of the extended quality team for operating system and service/ manufacturing tooling software releases across the Affera portfolio
- Collaborate with other quality team members to take accountability for completing assigned functional work within program deadlines
- 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
- Participate in software and process risk analysis and defect assessments 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
- Provide software quality support for post-market activities and analysis, including work supporting issue assessments, health risk assessments, and CAPAs
- Recommend design or test methods to achieve appropriate levels of reliability and security
- Propose changes to design or testing as necessary to improve software and/or process reliability
- Contribute to reliability 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 business needs permit, periodically visit manufacturing and servicing facilities to aid in understanding of quality processes related to software loading and tooling
- Regularly participate in virtual electrophysiology patient case learning opportunities
- Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements
Requirements
- Bachelor's degree and a minimum of 2 years of relevant experience OR Master’s degree with a minimum of 0 years of relevant experience
- Ability to demonstrate basic competency in coding, and effectively read, interpret, and understand existing software code
- Excellent written and oral communication skills
- 1+ years of industry experience working with a software development team
- Experience creating risk analysis documentation such as FMEAs and FTAs
- Experience using or working with products built on Python, Linux, Docker, Windows, AWS, REST APIs, React, and/or Flutter/Dart
- Knowledge of cybersecurity and the software lifecycle within regulated environments, including design, development, and post-market support
- Advanced degree in a relevant field
- Certification in quality systems or regulatory affairs (e.g., Six Sigma, ASQ, or similar)
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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