Staff Software Advanced Quality Engineer - Ai (Remote)

Why engineering at Stryker?

At Stryker we are dedicated to improving lives, with a passion for researching and developing new medical device products. As an engineer at Stryker, you will be proud of the work that you will be doing, using cutting-edge technologies to make healthcare better. Here, you will work in a supportive culture with other incredibly talented and intelligent people, creating industry-leading medical technology products. You will also have growth opportunities as we have a culture that supports your personal and professional development.

Need another reason to apply? Check out these 8 reasons to join Stryker's engineering team: https://www.strykercareersblog.com/post/8-reasons-to-join-strykers-engineering-team

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

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Staff Software Advanced Quality Engineer - AI (Remote)

California

Stryker is hiring a Staff Software Advanced Quality Engineer, to support our DRE (Digital, Robotics, and Enabling Technology) business.

As a valued member of Stryker’s AI innovation unit, you will work alongside trailblazers, industry visionaries, innovators, and inventors who are committed to bringing computer vision, AI/ML and digital innovation to the operating room and other healthcare settings.

You’ll contribute to fast-paced cycles of innovation and develop core technologies that power a wide array of Stryker’s solutions, including: surgical robotics and navigation, image-guided surgery, treatment selection, outcome assessment, and clinical decision intelligence. You will apply your core skills across a range of deployment platforms spanning from mobile applications, cloud services, and SDKs to embedded systems, edge devices, and mixed reality (XR) platforms. You will have an opportunity to work across a wide variety of therapeutic areas ranging from orthopedics and neurosurgery to emergency care and operating room safety and efficiency – plus many more.

Who we want:

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

Motivated product launchers. Engineers who bring strategic direction and drive for execution to ensure products are developed and launched with precision.

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

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

What you will do:

• Support critical analysis of technical situations and identification of problems. Work with cross-functional team in resolving the problems.
• Engage in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Quality Engineering function.
• Review and evaluate project tangibles for compliance as well as sound technical competence to ensure we are delivering robust products. Provide clear and timely feedback to stakeholders.
• Collaborate within cross-functional teams across multiple geographies to convey challenges, opportunities, solutions, and results in medical device new product development activities.
• Support software and system risk analysis, develop risk control measures, and support the creation of software risk analyses and test strategies to ensure safe and reliable products are launched to Stryker’s high quality standards.
• Guide New Product Development teams through our Quality Management System (QMS) and Software Development Lifecycle (SDLC) process to ensure software is developed in compliance to internal procedures as well as the requirements of the FDA, ISO, and other related regulatory bodies.
• Provide support to cross functional teams to ensure software quality objectives are met for medical device software development.
• Provide quality engineering input to impact the design, coding, and debugging of software in various coding languages including SOUP software.
• Support validation of new tools and approaches.
• Support software build, maintenance, defect management, and change control activities.
• Collaborate with other engineering disciplines, such as electrical, mechanical, and industrial design, to ensure that software will accomplish design goals for a product or system.
• Conduct evaluation of software engineering activities of medical device new product development including requirements, software risk analysis, and design, development, documentation, integration, verification, validation and release activities to deliver medical devices that are safe, secure and effective.

What you need:

• Experience in interpreting industry standards for medical device development and updating processes and procedures preferred.
• UL 2900-1 Cybersecurity Standard for Medical Devices
• IEC 14971 Risk Management
• SiMD IEC 62304
• Technical writing ability - clear and concise writing easily understood by multiple audiences (auditors, peers, etc.).
• SaMD IEC 82304
• IEC 81001-5-1 Health Software and Health IT Systems Safety, Effectiveness, and Security
• Must be able to handle multiple tasks/projects and manage priorities accordingly.
• Quality Management System ISO 13485
• Experience with and /or knowledge of the following desired:
  • Quality Management System ISO 13485
  • SiMD IEC 62304
  • SaMD IEC 82304
  • FDA 21 CFR 820.30
  • FDA CFR Part 11 Compliance
  • Knowledge of and experience with FDA General Principles of Software Validation
  • IEC 14971 Risk Management
  • IEC 81001-5-1 Health Software and Health IT Systems Safety, Effectiveness, and Security
  • UL 2900-1 Cybersecurity Standard for Medical Devices
• Knowledge of and experience with FDA General Principles of Software Validation
• FDA CFR Part 11 Compliance
• BS in a science, engineering, or related discipline.
• 4+ Years of Experience in the software engineering or quality field supporting new product development. Experience in medical device new product development preferred.
• Relevant work experience in software quality management of Class 2 or Class 3 medical devices including Software in Medical Device (SiMD) or Software as Medical Device (SaMD) preferred.
• FDA 21 CFR 820.30

$83,000 - $176,800 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com