Staff Engineer Software Design Quality
Staff Engineer Software Design Quality
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Salary Not Disclosed
1 Vacancy
Job Description
Stryker is hiring a Staff Engineer Software Design Quality to support our Medicals 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 premarket 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 inoffice 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:
Execute quality assurance activities for new product development within Strykers global Digital Health Portfolio focusing on Acute Care in the Medical Division.
Collaborate on software design development and validation strategies ensuring alignment with Quality Management Systems compliance requirements.
Partner with crossfunctional teams including marketing R&D clinical regulatory and operations to deliver quality compliant products.
Oversee risk management using ISO14971 standards to ensure product safety including defining critical quality attributes assessing residual risks and presenting risk/benefit justifications to executive leadership.
Drive continuous improvement across the software lifecycle by implementing software industry best practices and regulatory standards (FDA TGA EUMDR IT).
Engage in design and development activities for both medical and nonmedical software including SaMD MDDS and AI/ML solutions.
Implement standard development practices promoting methodologies like SAFe for mobile and cloudbased solutions to enhance efficiency and compliance.
Ensure cybersecurity data privacy and interoperability are integrated into digital product design reviewing software artifacts for compliance and traceability.
What you need:
Required:
Bachelors degree in a science or engineering.
Minimum of 4 years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D) Quality (QA/QC) or Systems Engineering.
Experience working through software lifecycle processes (Agile SAFe/Waterfall).
Experience with software Failure Modes Effect Analysis (sFMEA) Security Risk Assessments and defect management software testing and/or verification/validation.
Preferred:
Bachelors degree in Computer Engineering Electrical Engineering Software Engineering or Computer Science.
Experience with regulatory agencies (FDA MoH TUV) and medical device regulations 820 IEC 62304/with experience in Software as a Medical Device (SaMD) Software in a Medical Device (SiMD) and/or Digital Health Systems and Telehealth Solutions.
Experience with software technologies for mobile cloud and AI/ML solutions including Amazon AWS Microsoft Azure Apple or Android platforms
Experience in programming languages including C# Python Kotlin Java or TypeScript.
87600.00 to 186700.00 salary plus bonus eligible benefits. Actual minimum and maximum may vary based on pay is based on skills experience and other relevant factors.
Required Experience:
Staff IC
Employment Type
Full-Time
