Requisition ID 2577BR Job Title Staff Quality Design Engineer - Ultrasound Group MedSurg and Neurotech Division Sustainability Solutions Business Function Quality Assurance Country United States State/Province AZ City Tempe Employment Category Full Time Percent Travel Required Up to 10% Shift 1st About Stryker Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. Stryker products and services are available in over 100 countries. Job Description / InformationAs a Staff Quality Design Engineer-Ultrasound, for Stryker you will be a key member of the new product development team ensuring the implementation of cutting edge technology for medical devices is safe, effective, and compliant with industry practices. Working closely with R&D, Marketing, Advanced Operations, and Regulatory Affairs team members, you will be in a fast-paced environment with opportunities to win for yourself, the company, and patients around the world. This position is a hybrid between a traditional R&D Electrical 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. • Plans and leads departmental initiatives • 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. • Plans, designs, and /or implements difficult methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment. • Analyzes reports and recommends corrective action. • Plans and develops difficult process and product protocols and monitors progress. • Broad knowledge of applicable regulations and standards (e.g. QSR, ISO 13485) and how to apply the principles, practices, and procedures. • Provides and/or reviews advanced statistical techniques for test sample size determinations. • Uses and/or reviews advanced statistical rationale to plan, analyze, and interpret engineering test data collected during new medical device testing. • Plans, leads, monitors, and/or controls progress of difficult projects to ensure sound application of engineering principles are used, and design intent is being achieved. • Plans, selects, analyzes, designs, and/or improves difficult manufacturing procedures and engineering systems for medical devices. • Plans and verifies that new difficult engineering devices are technically sound and in compliance with FDA and other regulatory bodies. • Plans, performs, and reviews difficult engineering risk analyses to manage technical difficulties encountered with new medical devices. • Provides leadership in the product development process by identifying effective test methods. • Provides leadership and influence among multiple departments and teams such as R&D, Regulatory Affairs, Operations, and Marketing to ensure specific product development metrics are met. • Leads and/or facilitates periodic design reviews during the product development process. • Plans, improves, and/or supports advanced processes. • Demonstrates technical leadership as a departmental resource. • Provides leadership and mentoring to more junior staff. • 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. • May direct and/or evaluate the activities of one or more Design Quality Engineering technicians, Associate Design Quality Engineers, Design Quality Engineers, or Sr. Design Quality Engineers. Minimum Qualifications Desired Skills and Experience • Minimum of 5-6 years experience in ultrasound imaging industry. • Bachelor's degree in an engineering field. • Six Sigma Green Belt desired. • ASQ CQE desired • R&D and/or NPD experience preferred. • Strong verbal and written communication skills; ability to present issues, plans and objectives. • 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 All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability