Offer summary

Qualifications:

Bachelor's degree in science or engineering, preferably in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science., Experience in developing and assuring quality of Software in a Medical Device (SiMD) or Software as a Medical Device (SaMD)., Knowledge of regulatory standards such as FDA, TGA, EUMDR, and ISO14971., Experience with software technologies for mobile, cloud, or AI/ML solutions in healthcare contexts..

Key responsibilities:

Execute quality assurance activities for new digital health products.

Support software design, validation, and documentation compliance.

Collaborate with cross-functional teams to support product development and quality initiatives.

Participate in software lifecycle reviews and contribute to risk management and continuous improvement.

Job description

Work Flexibility: Hybrid or Onsite

Stryker is hiring a 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) to execute on Digital Health projects as a software design quality assurance engineer for pre-market new product development projects.

Workplace Flexibility & Location requirements: This is a hybrid role requiring the candidate to be within commuting distance of one of the following locations: San Jose, CA; Orlando, FL; Portage, MI; or Fort Wayne, IN. The work schedule is structured to support flexibility, with in-office presence required Monday through Wednesday and remote work available on Thursday and Friday. To qualify, candidates must be able to commute to one of these specific facilities as needed.

What you will do:

Assist in 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.

Preferred:

Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
Experience in the development and quality assurance of Software in a Medical Device (SiMD) and/or Software as a Medical Device (SaMD) solutions, applying 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 analysis methodologies and the creation and maintenance of detailed Failure Modes and Effects Analyses (FMEAs).
Experience through a previous role or internship in software or quality engineering, contributing to product development, testing, or compliance activities within a regulated environment.
Experience with software technologies for mobile, cloud, or AI/ML solutions (e.g., AWS, Azure, Apple, Android) and their applications in Telehealth, Healthcare IT, or Virtual Nursing solutions.

69,100.00 to 139,600.00 (based on the primary location of Portage, MI) - 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: 10%

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.

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