Stryker Senior Advanced Quality Engineer, Software in Redmond, Washington
It's time to join Stryker!
We are a great place to work. Fortune, in association with Great Place to Work, named us among the World’s Best Workplaces. We ranked #10 out of the 25 companies on the list. This list highlights companies that have gone above and beyond to create a great workplace for employees all over the world. Fortune also named us one of the 100 Best Companies to Work For in the United States. This is the seventh consecutive year we have been on the list, and we ranked 16 out of 100.
We aspire to create a place where hard work, humility, honesty, a sense of service and humor are the talk we walk. We are a very diverse group with an amazing set of experiences from bio-tech and high-tech companies. If that doesn't pique your interest, we’ve got scientists, motorcycle racers, some serious sailors, biking enthusiasts, whiteboard artists, videographers, mountain climbers, parents, triathletes, dog owners, avid runners, skiers and snowboarders. And we're always looking for players for our "awful"-ly fun summer volleyball tournament.
We combine laughter with intensity and focus. We have fantastic office space in the amazing Redmond-Woodinville Valley (yes, free parking), down the street from “Washington Wine Country”. We pay competitively, and offer full benefits to our Team Members.
In this role you will:
Provide quality assurance (QA) and quality engineering (QE) support to respective product line(s). Serve as a subject matter expert on the requirements and processes that result in the integration of the voice of the customer into the design and realization of products. Provide ownership for successful integration of appropriate Risk Management considerations into both design controls and issue resolution. Monitors field product performance for emerging trends and improvement opportunities for application to new product designs.
You will also:
Participate in the new product development process by ensuring that all the quality data streams (complaints, non-conforming records [NCRs], verified failures, etc.) are fully comprehended and that the voice of the customer, as heard through these data streams, is a design input and consideration.
Support Risk Management activities, including, but not limited to, the comprehensive and accurate assessment and characterization of software design risks, which includes both the appropriate mitigation activities and proper identification in downstream design outputs (design failure modes and effects analysis [DFMEA], Critical To Quality and Critical To Process characteristics on specifications, etc.).
Review and evaluate project documentation for compliance, as well as sound technical competence, to ensure we are delivering robust products. This includes non-product computer software validation.
Provide engineering input to impact the design, coding, and debugging of software in various coding languages, including SOUP software.
Collaborate with other engineering disciplines, such as mechanical, electrical, and industrial design, to ensure that embedded and system software will accomplish design goals for a particular product or system.
Participate in the CAPA process as task owner/contributor as appropriate and necessary.
Provide Quality leadership to drive the timely resolution of quality issues impacting assigned product lines.
Help guide New Product Development teams through our Quality Management System to ensure software is developed in compliance to internal procedures, as well as the requirements of FDA, ISO, and other regulatory bodies.
May mentor members of Advanced Quality Engineering team.
Other related duties as assigned.
What you need:
Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or equivalent combination of education and directly relevant experience
Minimum 5 years’ directly relevant experience, with a minimum of 2 years of recent prior experience in a high-tech or FDA/cGMP environment
We would love that you have these preferred qualifications:
Prior experience working with software development and/or software testing
ASQ certified software quality engineer (CSQE) and/or black belt certification
Excellent verbal and written communication skills
Demonstrated ability to work on complex problems with little to no guidance and under pressure
Knowledge of embedded software, system software, cloud solutions, software security
Demonstrated ability to drive and deliver innovative, effective and timely solutions
Demonstrated ability to mentor others in best practices and industry standards
Significant use of standard office equipment, including computer keyboard, monitor, and mouse
May require minimal domestic and international travel (<10%)
Work From Home: No
Travel Percentage: Up to 25%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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