Sr Reliability Engineer

is preferred. This position requires a strong team player who is a self-starter, inquisitive, and a fast learner. This role will be pivotal in ensuring the development of medical devices that drive successful design transfer.

• ◆Supplier selection and qualification while ensuring suppliers deliver quality parts, materials, and services.
• ◆Monitor parts from acquisition through the manufacturing cycle, promptly identifying and resolving supplier-related problems.
• ◆Evaluate supplier technical and manufacturing capabilities to meet product, process, quality, and business

as an input to supplier selection.

• ✓Manage Non-Conformance Material Reports (NCMRs) for material, components and production related issues, ensuring trends are identified, analyzed, and addressed across incoming, production, and sterilization areas.
• ✓Manage suppliers' change requests, including communication, project management, and regular reporting.
• ✓Manage the Approved Supplier List, from supplier evaluation, supplier agreement, supplier audits to supplier acceptance.
• ✓Qualify materials through the Production Part Approval Process (PPAP), including process validation, test method validation, technical writing, and project management.
• ✓Drive supplier performance improvement and reduce escapes to manufacturing through effective issue escalation, Supplier CAPA management, and Quality Performance Reviews.
• ✓Oversee Process validation (IQ/OQ/PQ) and Master Validation Planning in new product development.
• ✓Perform Statistical analysis of manufacturing process performance outputs
• ✓Oversee Process Failure Mode and Effect Analysis (internally and externally)
• ✓Collaborate cross functionally to ensure process limitations are captured within the design control, including Design Failure Mode and Effects Analysis and Design for Manufacturability and Assembly activities.
• ✓Collaborate cross functionally to ensure essential components, product features and respective process controls are identified.
• ✓Ensure Design Transfer effectively translates design specifications into production specifications.
• ✓Use project management skills to ensure that supplier processes are developing at the appropriate cadence to support engineering builds and Design Verification and Validation.
• ✓The job requires occasional travel to visit suppliers within the United States and internationally.

• ✓Education: Minimum bachelor’s degree in engineering, or a related technical field AND minimum 4 years of relevant experience. OR advanced degree with a minimum of 2 years relevant experience.
• ✓Technical Knowledge: Extensive understanding of manufacturing processes for plastics, metals, electronics and/or product level assembly. Extensive understanding of GD&T, FMEA, DFX principles.
• ✓Regulatory Knowledge: Extensive experience in a regulated environment.
• ✓Problem-Solving: Strong analytical and problem-solving skills with the ability to conduct thorough root cause analysis.
• ✓Communication: Excellent written and verbal communication skills, with the ability to effectively collaborate with cross-functional teams and present complex information to stakeholders.
• ✓Leadership: Proven leadership and project management skills with the ability to lead teams and manage multiple projects simultaneously.

• ✓Certifications : Certified Quality Engineer (CQE), Six Sigma Green Belt or equivalent certification, AAMI design control certification is preferred.
• ✓Regulatory Knowledge: In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
• ✓Technical Skills: Proficient in quality management systems, risk management, regulatory compliance, and statistics. Lead auditor experience.
• ✓Other: Basic knowledge of human anatomy/physiology and surgical procedures
• ✓Tools: SAP, Trackwise, Windchill, Agile

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.