Senior Design Quality Engineer

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

Stryker is hiring a Senior Design Quality Engineer in Tempe, AZ.

Who we want:

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.

Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

What you will do:

As a Senior Design Quality Engineer 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 Engineer and a traditional Quality Engineer.

• 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.
• 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.
• Plans and leads departmental initiatives
• 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.

Supervisory Responsibilities

• May train others in quality assurance / GMP related topics.
• May direct and/or evaluate the activities of one or more Advanced Quality Engineering technicians, Associate Advanced Quality Engineers, or Advanced Quality Engineers.

What you will need:

Basic Qualifications:

• Bachelor's degree in an engineering or science field.
• 2+ years’ experience in quality, NPD, and/or experience in a highly regulated industry

Preferred Qualifications:

• Bachelor’s in Electrical Engineering and/or related discipline
• Electronics experience a plus (PCBAs, etc.)
• 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
• Six Sigma Green Belt or ASQ CQE desired.
• R&D and/or NPD experience preferred.

Computer Skills

• Proficient in Microsoft Word, Excel, Power Point, Outlook.
• Familiarity with one or more programming languages

Work Environment

• Office/Manufacturing
• Work is normally performed in a typical interior/office work environment.
• No or very limited exposure to physical risk
• While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands to finger, handle, or feel objects; reach with hands and arms; balance; stoop, kneel, or crouch; talk or hear.
• The employee may occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• While performing the duties of this job, the employee is exposed to weather conditions prevalent at the time.
• The noise level in the work environment is usually moderate.
• May be exposed to Hazardous materials. Employees need to consult MSDS in their work area.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.