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
Who we want - Experience in Medical Device Highly Preferred!
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
Dedicated achievers. Relentless about quality, people who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices.
What you will do
Stryker is one of the worlds' s leading medical technology companies, dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care.
As a Sr Software Quality Assurance Engineer will be working with cutting edge medical imaging and robotic technologies and medical devices. Your work will help bring new medical devices to market by providing guidance to the development team through the Software Development and New Product Development processes.
As a Software Quality Engineer you are responsible for quality system support for R&D projects; generation and/or review of software documentation; provide inputs to software R&D designs; develop test strategies for software systems; improve quality processes as they apply to software systems.
If you are excited by opportunities that help develop and execute software quality assurance through verification strategies and test scripts, ensuring that documentation is accurate and supports regulatory submissions then please APPLY NOW!
You will be responsible for the complete life cycle of a new/modified software product, from research and design to implementation, training and support.
You will co-develop software solutions by studying information needs; conferring with users; studying systems flow, data usage, and work processes; investigating problem areas; by developing documentation, flowcharts, layouts, diagrams, charts, code comments and clear code while following the software development lifecycle.
You will partner with Product Development to define requirements that will ensure appropriate level of rigor to software validation
You will lead Risk Management activities throughout the product development life cycle. Perform formal risk analysis, develop software risk control measures and mitigations, and create SFMECA in support of risk management.
You will partner with PD to define design verification and validation test requirements that will ensure appropriate objective evidence is available to support the acceptance criteria
Provide guidance to the development team through Software Development and New Product Development process including demonstrating understanding of software lifecycle methodologies (e.g. Waterfall, Agile).
Responsible for Software test and quality assurance including software verification strategies, test scripts and traceability to requirements.
What you need
Bachelor's degree in Engineering, Computer Science, Physics or related discipline.
Prefer CQE certification or equivalent and Six Sigma Green or Black
0+ years' experience working in a highly regulated environment, software related role, engineering, quality, manufacturing, or new product development highly preferred.
Knowledge of medical device product development life cycle, including risk management and design/ process verification & validation and computer software validation preferred.
Preferred knowledge of FDA QSRs, ISO 13485 Design Control Procedures, IEC 62304 and ISO 14971
Understanding of Software Design, Software Debugging, Software Documentation, Software Testing, Software Development Fundamentals, Software Development Process, Software Requirements preferred.
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 products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. Stryker is active in over 100 countries around the world.
Together with our customers, we are driven to make healthcare better.
At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by
providing innovative products and services that meet regulatory requirements through our effective quality system.
The Company was founded in 1941 by Dr. Homer Stryker and incorporated in 1946 as the Orthopedic Frame Company. In 1964, the Company’s name was changed to Stryker Corporation.
• $13.6 billion in annual sales in 2018; annual revenue has grown for 39 straight years
• 17.1% CAGR (compound annual growth rate) in sales over 39 years
• ~36,000 employees globally in 2018
• 43 manufacturing and research & development locat...ions worldwide
• Included in the Standard & Poor’s 500 Index
• Ranked # 233 on Fortune Magazine’s “FORTUNE 500” list for 2019
• Ranked # 3 on Fortune Magazine’s “World’s Most Admired Companies” list for the “Medical Equipment” industry for 2019
• Ranked # 11 on Fortune Magazine’s “100 Best Companies to Work For” list (U.S.) for 2019
• Spent $862 million on R&D in 2018
• 7,784 patents owned globally in 2018
• Initial public offering of stock was in 1979
• Listed on the New York Stock Exchange under ticker SYK