Senior Quality Engineer

Medtronic (www.medtronic.com), is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic's mission is: To contribute to human welfare by application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life.

* Conduct all engineering activities in compliance with FDA Regulations, ISO 13485, MDD, CMDR, CMDCAS and other national and international quality and regulatory requirements and standards. * Lead the product quality assurance and quality engineering aspects of activities to drive strong engineering and technical knowledge and application. * Establish quality assurance, engineering programs, and initiatives to ensure products and assemblies are developed and manufactured in accord with applicable requirements. * Conduct investigations, root cause analysis and provide corrective and preventive actions based on sound engineering analysis and review. Provide effective solutions that will drive continuous and measurable improvements. * Work closely with Manufacturing/Operations, R&D and other departments to ensure highest quality products and processes are developed and deployed and are engineering sound. This includes product design testing, process testing, characterization, qualification, validation, risk analysis/FMEA, etc. * Demonstrate and educate use of quality engineering tools (Lean Sigma) within the organization to drive methodical approach to design and process development, implementation and improvement. Apply same approach to existing processes including utilization of new technologies. The tools include, but are not limited to, six sigma, analytical statistics, advanced statistical engineering, design of experiments, and other proven tools. * Demonstrate superior engineering/critical thinking based on both driving business objectives and product quality improvements. * Demonstrate solid understanding of internal and applicable external policies, procedures and standards. * Develop systems for the identification, analysis, correction, and prevention of quality issues. * Work with local regulatory compliance manager to ensure effective compliance to the product development protocol and other applicable systems. * Manage quality engineers and/or technicians as assigned and provide technical leadership. * Participate in projects as assigned including operations and/or R&D projects. * Communicate issues and opportunities to manager. * Work in a clean room and laboratory. * Exposure to some chemicals.

**Basic Qualifications** • BS degree in Engineering or Science. • 5+ years experience in a highly regulated field. **Desired/Preferred Qualifications** * 5+ years expertise in Class (II) or Class (III) Medical Device Industry. * Certificate of Professional Engineer (PE) or MS Degree. * Lean Sigma training or certification. * Certified Quality Engineer (CQE) * Certified Quality Auditor (CQA) * Knowledge of GMP, ISO 13485, MDD, CMDR, CMDCAS * Training in Process Improvement. * Good written and verbal communication skills * Quality Engineering Statistical Tools. * Presentation. * Excellent PC skills. * Strong problem solving skills. * Good people management skills. * Effective interpersonal skills. * Supervisory skills. * Effective project management skills.