Senior Software Quality Engineer, Post Market
About the position
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. 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.
Responsibilities
• Executing quality assurance activities for new product development within Stryker's global Digital Health Portfolio.
• Supporting software design and validation efforts by ensuring documentation aligns with Quality Management Systems compliance requirements.
• Collaborating with cross-functional teams (e.g., marketing, R D, regulatory) to support product development and quality initiatives.
• Contributing to risk management documentation under guidance, referencing ISO14971 standards to support product safety assessments.
• Independently executing QA activities for digital health products, ensuring compliance with global regulatory standards (FDA, TGA, EUMDR).
• Participating in software lifecycle reviews, promoting continuous improvement and adherence to industry best practices.
• Engaging in the design and development of medical and non-medical software, including SaMD and MDDS, with growing autonomy.
• Applying standard development methodologies such as SAFe to support mobile and cloud-based solution development.
Requirements
• 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, testing, or compliance activities.
Nice-to-haves
• Bachelor's degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
• Experience supporting the development or quality assurance of Software in a Medical Device (SiMD) and/or Software as a Medical Device (SaMD) or Software as a non-medical device (SaND) with exposure to both Waterfall and Agile methodologies and an understanding of regulatory requirements.
• Foundational knowledge or hands-on experience in cybersecurity or secure software development; certification such as Security+ or CISSP is a plus.
• Familiarity with risk analysis and contributing to Failure Modes and Effects Analyses (FMEAs) is desirable.
• Exposure to mobile, cloud, or AI/ML technologies (e.g., AWS, Azure, iOS, Android), especially in healthcare IT, telehealth, or virtual care environments.
Benefits
• Salary range of $77,200.00 to $160,800.00 plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Apply Now
Apply Now
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. 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.
Responsibilities
• Executing quality assurance activities for new product development within Stryker's global Digital Health Portfolio.
• Supporting software design and validation efforts by ensuring documentation aligns with Quality Management Systems compliance requirements.
• Collaborating with cross-functional teams (e.g., marketing, R D, regulatory) to support product development and quality initiatives.
• Contributing to risk management documentation under guidance, referencing ISO14971 standards to support product safety assessments.
• Independently executing QA activities for digital health products, ensuring compliance with global regulatory standards (FDA, TGA, EUMDR).
• Participating in software lifecycle reviews, promoting continuous improvement and adherence to industry best practices.
• Engaging in the design and development of medical and non-medical software, including SaMD and MDDS, with growing autonomy.
• Applying standard development methodologies such as SAFe to support mobile and cloud-based solution development.
Requirements
• 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, testing, or compliance activities.
Nice-to-haves
• Bachelor's degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
• Experience supporting the development or quality assurance of Software in a Medical Device (SiMD) and/or Software as a Medical Device (SaMD) or Software as a non-medical device (SaND) with exposure to both Waterfall and Agile methodologies and an understanding of regulatory requirements.
• Foundational knowledge or hands-on experience in cybersecurity or secure software development; certification such as Security+ or CISSP is a plus.
• Familiarity with risk analysis and contributing to Failure Modes and Effects Analyses (FMEAs) is desirable.
• Exposure to mobile, cloud, or AI/ML technologies (e.g., AWS, Azure, iOS, Android), especially in healthcare IT, telehealth, or virtual care environments.
Benefits
• Salary range of $77,200.00 to $160,800.00 plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Apply Now
Apply Now