Stryker is hiring a Senior Software Design Quality Engineer to support our Medical’s Digital Health division and portfolio Software as a Medical Device (SiMD) or Software in a Medical Device (SiMD) and Software as a non-medical device (SaND) to execute on Digital Health projects as a software design quality assurance engineer for pre-market new product development projects.
Workplace Flexibility & Location:
This hybrid role requires candidates to be within commuting distance of one of the following locations: San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN. The standard schedule includes on-site work Monday through Wednesday, with remote work on Thursday and Friday. Candidates must be able to commute to their designated facility as needed.
What you will do:
Execute quality assurance activities for new product development within Stryker's global Digital Health Portfolio.
Collaborate on software design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements.
Partner with cross-functional teams (e.g., marketing, R&D, regulatory) to support product development and quality initiatives.
Contribute to risk management using ISO14971 standards to support product safety assessments.
Independently execute QA activities for digital health products, ensuring compliance with global regulatory standards (FDA, TGA, EUMDR).
Participate in software design reviews, promoting continuous lifecycle improvement and adherence to industry best practices.
Engage in the design and development of medical and non-medical software, including SaMD and MDDS, with growing autonomy.
Apply standard development methodologies such as SAFe to support mobile and cloud-based solution development.
What you need:
Required:
Bachelor’s degree in science or engineering related discipline.
Minimum of 2 years of experience as an Engineer in software or quality engineering, contributing to product development and compliance activities.
Proficiency in risk analysis, software design controls, and defect management.
Experience with software technologies for mobile, cloud, or AI/ML solutions (e.g., AWS, Azure, Apple, Android).
Preferred:
Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
Experience with software development, system requirements, and Design History Files of Software in a Medical Device (SiMD) and/or Software as a Medical Device (SaMD) solutions
Experience with both Waterfall and Agile methodologies to ensure regulatory compliance and efficient delivery across the software lifecycle.
Cybersecurity certification (e.g., CISSP, Security+, or equivalent) or demonstrated experience in secure software development, with a strong foundation in risk management methodologies and the creation and maintenance of detailed Failure Modes and Effects Analyses (FMEAs).
Experience in Telehealth, Healthcare IT, or Virtual Nursing solutions
87,600.00 To 186,700.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
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What We Do
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com.
Together with our customers, we are driven to make healthcare better.
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