Quality Control professional overseeing manufacturing processes in Netherlands production. Monitoring production yields and driving quality improvements through root cause and failure analysis.
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)
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
Senior Supplier Quality Engineer ensuring quality in the production of medical devices across multiple units at Medtronic. Collaborating with engineering teams to improve processes and supplier relations in Colorado.
Customer Quality Engineer Manager at Cisco leading quality management for strategic customers. Driving insights to improve product performance and support in a high - impact quality engineering role.
Lead Engineer developing automatic test equipment and test programs for power electronics testing. Collaborating with teams to deliver high - quality assembled products in manufacturing.
Head of QA leading the transformation of quality assurance at an iGaming company. Overseeing a team and driving brand - centric quality assurance initiatives.
Quality Assurance Technician ensuring production process stability at Vestas. Analyzing defects and supporting production operators in a full - time on - site role in Goleniów.
Leads QA efforts ensuring web applications meet customer requirements effectively in Agile environments. Builds automated testing while mentoring QA team members in Pune, India.
Quality Assurance Tester designing and executing test cases at PolicyStreet, a leading insurtech group in Asia. Focus on manual and automation testing while managing issues and defects.
Lead QA Engineer responsible for ensuring software quality and compliance in healthcare regulations. Collaborate with teams to develop testing strategies and mentor QA engineers.
Senior QA Engineer responsible for designing, testing, and delivering high - quality software solutions with a cross - functional team. Engaging in CI/CD processes and ensuring quality throughout product releases.