Senior Software Quality Engineer, Post Market
Senior Software Quality Engineer, Post Market
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1 Vacancy
Job Description
Stryker is hiring a Senior Software Design Quality Engineer to support our Medicals 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 includeson-site work Monday through Wednesday withremote 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 Strykers 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:
Bachelors 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:
Bachelors 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.
77200.00 to 160800.00 salary plus bonus eligible benefits. Actual minimum and maximum may vary based on 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 contractors legal duty to furnish information.Required Experience:
Senior IC
Employment Type
Full-Time
