Introduction to Stryker and Our Mission
Stryker is a leading medical technology company that is committed to making healthcare better. We are driven by a passion to improve lives and a desire to make a positive impact on the world. Our company is built on a foundation of innovation, quality, and customer satisfaction, and we are dedicated to delivering exceptional products and services that exceed our customers' expectations. As a Staff Software Advanced Quality Engineer – AI, you will play a critical role in helping us achieve our mission by ensuring the quality and safety of our medical device software products.
Job Overview
We are seeking an experienced Staff Software Advanced Quality Engineer – AI to join our team in Menlo Park, CA. As a valued member of our AI innovation unit, you will work alongside talented engineers, innovators, and industry visionaries who are committed to bringing computer vision, AI/ML, and digital innovation to the operating room and other healthcare settings. You will 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.
Key Responsibilities
- Guide New Product Development teams through our Quality Management System (QMS) and Software Development Lifecycle (SDLC) process to ensure software is developed in compliance with internal procedures as well as the requirements of the FDA, ISO, and other related regulatory bodies.
- 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.
- 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.
- 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 and support cross-functional teams to ensure software quality objectives are met for medical device software development.
- Collaborate within cross-functional teams across multiple geographies to convey challenges, opportunities, solutions, and results in medical device new product development activities.
- Engage in continuous improvement initiatives to establish a Center of Excellence (CoE) in Software Quality Engineering function.
- Provide quality engineering input to impact the design, coding, and debugging of software in various coding languages, including SOUP software.
- 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.
- Support validation of new tools and approaches.
Essential Qualifications
- 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.
- Experience in interpreting industry standards for medical device development and updating processes and procedures preferred.
- Knowledge of and experience with FDA General Principles of Software Validation, IEC 14971 Risk Management, and 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.
- Technical writing ability - clear and concise writing easily understood by multiple audiences (auditors, peers, etc.).
Preferred Qualifications
- Experience with Quality Management System ISO 13485, SiMD IEC 62304, and SaMD IEC 82304.
- Knowledge of FDA 21 CFR 820.30 and FDA CFR Part 11 Compliance.
- Experience with UL 2900-1 Cybersecurity Standard for Medical Devices.
- Strong understanding of software development methodologies, such as Agile and Scrum.
- Experience with continuous integration and continuous deployment (CI/CD) pipelines.
- Strong analytical and problem-solving skills, with the ability to identify root causes and recommend comprehensive upgrades.
- Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
Career Growth Opportunities and Learning Benefits
At Stryker, we are committed to helping our employees grow and develop in their careers. As a Staff Software Advanced Quality Engineer – AI, you will have access to a wide range of training and development opportunities, including:
- On-the-job training and mentorship from experienced engineers and quality professionals.
- Formal training programs, such as our Quality Engineering Development Program.
- Opportunities to attend industry conferences and workshops.
- Access to online learning platforms and resources.
- Cross-functional training and development opportunities.
Work Environment and Company Culture
At Stryker, we are proud of our company culture, which is built on a foundation of innovation, quality, and customer satisfaction. Our work environment is fast-paced and dynamic, with a focus on collaboration and teamwork. We offer a wide range of benefits and perks, including:
- Competitive salary and bonus structure.
- Comprehensive benefits package, including health, vision, and dental insurance.
- 401(k) retirement savings plan with company match.
- Tuition reimbursement program.
- Employee assistance program.
- Wellbeing program.
- Employee stock purchase program.
- Flexible work arrangements, including remote and hybrid work options.
- Opportunities for professional growth and development.
Compensation, Perks, and Benefits
We offer a competitive salary range of $83,000 - $176,800 per year, depending on experience and qualifications. In addition to our competitive salary, we offer a wide range of benefits and perks, including:
- Bonus eligibility.
- Comprehensive benefits package.
- 401(k) retirement savings plan with company match.
- Tuition reimbursement program.
- Employee assistance program.
- Wellbeing program.
- Employee stock purchase program.
- Flexible work arrangements.
Conclusion
If you are a motivated and experienced software quality engineer with a passion for medical device development and AI, we encourage you to apply for this exciting opportunity. As a Staff Software Advanced Quality Engineer – AI at Stryker, you will play a critical role in helping us achieve our mission of making healthcare better. You will have the opportunity to work on challenging and rewarding projects, collaborate with talented engineers and quality professionals, and develop your skills and expertise in a fast-paced and dynamic environment. Don't hesitate to apply – we look forward to hearing from you!
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