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.