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:
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.
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, testing, or compliance activities.
Preferred:
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.
77,200.00 to 160,800.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
Travel Percentage: 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.