Sr QA Engineer

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.
Sr QA Engineer
Santa Rosa, CaliforniaThe Senior Quality Assurance Engineer provides technical QA support and recommendations on new product development and other projects focused on business and manufacturing process improvements.The Senior Engineer will be responsible for project management and decision-making support to other product development team members.
Responsibilities: Design Development and Assurance
Lead polymer characterization and testing activities
Analyze processing effects on polymers to ensure reliable and repeatable product qualitty
•Provide technical support as a team member on new product development project teams to improve planning
•Develop, evaluate, procure and install equipment used to measure and evaluate product performance
•Drive test method validations by using statistical tools
•Create quality and test plans to support design verification & validation
•Verify and validate on new or modified product designs
•Mitigate risk management from product concept to product launch. Facilitate team consensus on inputs to design-FMECA and process-FMECA.
•Determine solutions with team regarding failure analysis of returned devices.•Process Development and Assurance
•Implement process validation activities across multiple manufacturing sites.
•Test statistically sound sampling plans and process control plans. Identify critical inspection characteristics in a manufacturing process.
•Develop a thorough knowledge of all equipment and facilities used in the stent and catheter manufacturing processes
•Communicate to team members issues regarding non-conforming material reports and corrective action reports, ensuring implementation and solution of issues
•Develop and implement quality systems to achieve and maintain FDA facility registration, ISO certification and CE marking
•Facilitate improvement of manufacturing and business processes through use of six-sigma, lean manufacturing, DOE and other tools.
•Ensure quality support to manufacturing floor activities, such as SPC implementation, process analysis, and monitoring of process control measures.
•Supplier Management
•Develop process to identify qualified suppliers
•Coordinate first article testing and other required testing to ensure process/equipment validation to Receiving Inspection
REQUIREMENTS
The successful candidate will possess:•MS in Polymer Science, Polymer Engineering, Chemical Engineering, Bioengineering, or Biotechnology with 5+ years of experience in product and process development
iin the medical device industry with significant experience working with polymers; polymer analysis techniques, GPC, IR, GC. Experience with Proton NMR, HPLC preferred.•JOB QUALIFICATIONS•Excellent prioritization and verbal/written skills
•Effectively communicates and collaborates across all levels of the organization
•Encourage and adopt new ways of looking at problems, processes and solutions•Adapt to competing demands and shifting prioritiesSPECIAL LICENSE OR CERTIFICATIONS
•ASQ Certified Quality Engineer or Six Sigma Black Belt a plus
•Internationally certified quality auditor designation a plus
We are currently seeking multiple individuals for Engineering 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 Santa Rosa, California. Other opportunities may also exist at our locations in Minneapolis, Minnesota; Northridge, 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 # 51873 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.