Senior Software Quality Engineer, Post Market

About the Role

Key Responsibilities

• Executing quality assurance activities for new product development within Stryker's global Digital Health Portfolio.
• Support software design and validation efforts by ensuring documentation aligns with Quality Management Systems compliance requirements.
• Collaborate with cross-functional teams (e.g., marketing, R D, regulatory) to support product development and quality initiatives.
• Contribute to risk management documentation under guidance, referencing 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 lifecycle reviews, promoting continuous 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.

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 Have

• 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.

Qualifications

• Bachelor's degree in science or engineering related discipline.
• Minimum of 2 years of experience in software or quality engineering.

Benefits & Perks

• Salary range from $77,200.00 to $160,800.00 plus bonus eligible.
• Benefits (specifics not detailed in the description).