Design Quality Engineer, Sr. – Tempe, AZ

Stryker Sustainability Solutions is the leading provider of reprocessing and remanufacturing services for medical devices as well as comprehensive recycling and redistribution initiatives. Stryker was the first global Original Manufacturer (OM) to offer innovative, cost-effective programs, such as reprocessing and remanufacturing, to help meet the resource management demands of its hospital partners. Stryker’s programs specifically target inefficient practices and reclaim and redirect consumable and financial resources in order to promote healthy and responsible hospitals. Stryker customers include most of the “Honor Roll” hospitals recognized by U.S. News & World Report.The Design Quality Engineer is responsible for creating and implementing the Risk Management File, demonstrating statistical expertise, and injecting the voice of quality to assure quality and compliance for New Product Development (NPD) teams. This position is a hybrid between a traditional R&D Engineer and a traditional Quality Engineer.

Essential Duties and Responsibilities:
– Represents Quality Assurance on the New Product Development (NPD) cross-functional team (CFT).
– Interfaces among multiple departments and teams such as R&D, Regulatory Affairs, Advanced Operations, and Marketing to ensure specific product development metrics are met.
– Creates and implements the Risk Management File for an NPD team.
– Leads Risk Management activities for an NPD team, including identifying hazards and harms that may be associated with the medical device.
– Leads Design Reviews for NPD teams to ensure design and process robustness and compliance to Corporate and Divisional design control procedures.
– Leads the exercise of understanding the functional inputs and outputs of the medical device.
– Analyzes, reviews, and approves standard methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment and recommends corrective action.
– Analyzes, reviews, and approves standard manufacturing procedures and engineering systems for medical devices.
– Analyzes, reviews, and approves equipment qualifications in preparation for design verification testing and/or process validation testing.
– Analyzes, reviews, and approves test methods to ensure repeatability and reproducibility.
– Analyzes, reviews, and approves standard process and product protocols.
– Analyzes, reviews, and approves reports and recommends corrective action.
– Provides sound statistical rationale for test sample size determinations.
– Analyzes test data by using sound statistical techniques and communicating the results
– Uses sound statistical rationale to analyze and interpret engineering test data collected during new medical device testing.
– Verifies that new medical devices are technically sound and in compliance with FDA and other regulatory bodies.
– Fundamental knowledge of applicable regulations and standards (e.g. QSR, ISO 13485)
– Improves and/or supports existing processes.
– Supports team initiatives
– May interact with customers to solve product quality issues and /or answer general product questions.
– May work with verbal and/or written instructions.
– May train others in quality assurance / GMP related topics.

Education & Experience:
– Bachelor’s degree in an engineering or science field.
– Minimum of 5 years experience in Mechanical, Electrical, Chemical, Material Science, and/or Biomedical Engineering.
– R&D and/or NPD experience preferred.
– Proficient in Microsoft Word, Excel, Power Point, Outlook, Project
– Experience with statistical software packages such as Minitab or JMP is desired.

Qualifications
– Strong verbal & written communication skills.
– Excellent organizational, problem solving, and analytical skills
– Ability to manage priorities and workflow
– Versatility, flexibility, and a willingness to work within constantly changing priorities
– Ability to handle multiple projects and meet deadlines.
– Good judgment with the ability to make timely and sound decisions.
– Working knowledge of data collection, data analysis, and evaluation, and scientific method.
– Ability to observe and note minute inconsistencies.
– Ability to generate, follow, and explain detailed instructions and inspection procedures.
– Ability to complete detailed documentation accurately.
– Ability to analyze and resolve routine issues using independent judgment.

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2053878-1793-4376