Design Assurance Engineering Manager

Medtronic. Careers with a passion for life.As the world’s leading medical technology company, we provide lifelong solutions to people with chronic disease. Everything we do is deeply rooted in our mission—to alleviate pain, restore health, and extend life. Every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. We also are dedicated to the total well-being of our employees and have been recognized for seven of the last nine years by Fortune magazine as one of the "100 Best Companies to Work For in America." Work with the kind of people who not only love what they do but why they do it.
Design Assurance Engineering Manager
Minneapolis, MinnesotaLead the Design Assurance function to develop products of high quality and reliability in partnership with other functions within the Neuro division .
Responsibilities: Lead the Design Assurance Reliability Engineers in their efforts to ensure that the product development projects are utilizing appropriate Risk Assessment, Verification, and Validation methods for producing high quality products. Responsible jointly with the product development group for the procedures used to ensure that Design Control Regulations are adequately implemented and used effectively. Design Assurance Manager maintains a thorough understanding of regulations and guidelines (FDA, MDD, ISO, etc.). She/he manages department budgets and provides coaching and guidance for engineers in the department. The department assists development engineering in development of robust designs and processes by providing training and consultation on the use of FMEA, Design of Experiments, and Process Capability Techniques. The manager ensures that reliability engineers have the appropriate training to lead risk analysis evaluation and product validation plans and reports. The manager ensures that the department has expertise in electrical and mechanical test methods, failure analysis, and use of statistical methods for all aspects of product and process development. The Design Assurance department retains close ties to the Product Performance Department and keeps abreast on Product Performance information so that relevant input can be provided to the Product Development teams. The Design Assurance Manager participates in driving improvements in the Neuro Quality System. Design Assurance Manager may participate in some product development projects as a Quality Core Team Member.
REQUIREMENTS
MINIMAL REQUIREMENTS: Bachelor of Science in Engineering or related field. Minimum of 10 years in manufacturing, quality, development engineering or operations, with at least 2 years of experience in a medical device operation and at least 2 years management or supervisory experience. Must possess strong leadership skills and the ability to communicate effectively at all levels within the organization and with gobal business partners. Must possess be able to coach and motivate subordinate staff. Must understand manufacturing and processing principles. Knowledge of FMEA, Reliablility Analysis, DOE, SPC and Process Capability techniques. Proficient in use of computer applications, Word, Excel, MSProject, DOE Software.
PREFERRED REQUIREMENTS: Masters of Science or Master of Business Administration. Prefer CRE, CQE, or CQM.
We are currently seeking multiple individuals for Regulatory Affairs & QA opportunities throughout Medtronic. Qualified candidates with all levels of experience are encouraged to submit an application in consideration for this or similar opportunities. This opportunity is based in Minneapolis, Minnesota. Other opportunities may also exist at our locations in Northridge, California; Santa Rosa, California; Redmond, Washington; Denver (Louisville), Colorado; Ft. Worth, Texas; Memphis, Tennessee; Danvers, Massachusetts; and Jacksonville, Florida.With people like you who have purpose, potential and passion, we’ll supply physicians and their patients around the world with the means to alleviate pain, restore health and extend life.
TO APPLY: Please submit your resume at www.medtronic.com/employment. Review Regulatory Affairs openings or enter Requisition # 51971 and select "Add to Cart" or "Apply to this Job" to route your resume directly to the hiring department. No agencies or phone calls, please.
Medtronic is an equal opportunity employer committed to cultural diversity in the workforce.