Supplier Quality Engineer II - Software - CRM

Medtronic • Mounds View, MN

2d • $84,000 - $126,000 • Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Supplier Quality Engineer II - Software Careers That Change Lives In this exciting role as a Supplier Quality Engineer II - Software you will have responsibility for review and approval of software elements and software of unknown provenance (SOUP) items developed outside of Medtronic; partnering with sourcing teams for the selection, evaluation, approval and ongoing performance monitoring of software suppliers; and working with software development and New Product Development teams to qualify and release software product to support CRM and CDS products and devices. CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions. The Cardiac and Vascular Group brings all our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. We believe that when people from different cultures, genders, and points of view come together, innovation is the result —and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. This position is in Mounds View, MN. within the Cardiac Rhythm Management (CRM) operating unit. 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 are working on-site 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role will require less than 10% of travel to enhance collaboration and ensure successful completion of projects. A Day in the Life In general, the following responsibilities apply for the Supplier Quality Engineer II - Software role. This includes, but is not limited to the following:

Requirements

• Bachelor’s degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering or Engineering and minimum of 2 years of work experience OR advanced degree in Computer Engineering, Software Engineering, Computer Science, Electrical Engineering or Engineering with 0 years of work experience in engineering and/or quality.

Nice To Haves

• Understanding of IEC 62304 Medical device software – Software life cycle processes and ISO 13485/9001
• Lead Auditor Experience
• Experience working with vendors and suppliers
• Familiarity with software with unknown provenance (SOUP) components and SOUP validation.
• Risk Management experience
• Knowledge of Design for Six Sigma (DFSS), Design for Lean Sigma (DFLS), Design for Reliability and Manufacturability (DRM), or other robust design practices

Responsibilities

• Participant in software selection teams to evaluate and approve software suppliers.
• Evaluates the quality impact of supplied software products and services and applies necessary supplier controls as appropriate.
• Partners with Sourcing team to add new suppliers, products, and services to the Approved Supplier List, and maintains the ASL for software suppliers.
• Ensures that suppliers deliver quality products and services.
• Qualifies suppliers according to company standards.
• Monitors Suppliers/products from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
• Performs periodic audits of software suppliers to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Provides Pre-Market Quality Engineering support to New Product Development (NPD), working in partnership with the Post-Market Supplier Quality Teams and Sourcing teams, to deliver quality products, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
• Provides technical guidance and quality compliance for Supplier Quality Engagement throughout the NPD lifecycle on newly qualified parts and implements strategies for driving product quality and continuous improvement, ensuring purchased products are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees