Stryker Senior Design Quality Engineer in Salt Lake City, Utah
Who we want
Challengers – People who seek out the hard projects and work to find just the right solutions.
Teammates – Partners who listen to ideas, share thoughts and work together to move the business forward.
Initiative - People who take ownership of deliverables, seek out opportunities and drive projects to completion
Problem Solving – People who can take on complex problems and make data based decisions
Communication – People who can communicate project progress, data analysis and conclusions effectively
Responsibility – People who see things through to completion and take personal accountability for end results
Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com (http://www.stryker.com/) .
Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke, and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters.
In March 2018, Stryker Corporation (NYSE:SYK) announced that for the eighth consecutive year, it has been named as one of the FORTUNE 100 Best Companies to Work For, ranking 16 out of 100.
What you will do
In this Senior Design Quality Engineer position, you will be involved in supporting fast paced product design change efforts. You will be responsible for developing qualification plans, protocols, perform product testing and failure analysis, writing reports. You will make regular use of problem solving tools and statistical analysis to perform test method development and validation, design verification, risk assessment and design reviews.
As a DQE, you will be responsible for product risk management and adherence to design control requirements throughout the product lifecycle. You will create and maintain risk files and assess the impact of necessary changes to our products. Remediation of existing risk files will require discussions with Medical Safety, R&D, Marketing, and Regulatory Affairs to bring the files into compliance with current best practices.
NV products push the boundaries of technology to meet ever increasing product performance requirements, making the goal of assessing and demonstrating safety, performance and compliance an exciting challenge.
What you need
Bachelor’s degree in Engineering, Science or similar field
3+ years of experience in engineering, quality, new product development, working in a highly regulated environment
2+ years of experience in Medical Device or Pharmaceutical industries
Experience in Design Control, Risk Management, and Statistical Analysis
Experience in Human Factors/Usability Engineering desired