Senior Quality Engineer Medtronic, a global leader in medical technology, services, and solutions, is seeking a highly skilled and experienced Senior Quality Engineer to join our innovative team. This role will be in the Surgical Operating Unit within the new product development quality team to influence design based on manufacturability, inspection and assembly, interact with suppliers (internal and external) to develop robust processes to manufacture the parts and assemblies, qualify the manufacturing processes established to produce sustainable supply and maintain supply and manufacturing continuity until product transfer. The ideal candidate will bring a strong background in manufacturing processes, manufacturing process development, process controls, process validation and supplier management. The role also supports medical device product development, and a solid understanding of design controls and regulatory compliance requirements 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.
Key Responsibilities:- 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 requirements 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.
Qualifications
Minimum Requirements
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.
Preferred Qualifications
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
