Staff Software Quality Engineer – Design Assurance
| Company | Stryker |
|---|---|
| Location | Orlando, FL, USA, San Jose, CA, USA, Portage, MI, USA, Fort Wayne, IN, USA |
| Salary | $87600 – $186700 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Mid Level, Senior |
Requirements
- Bachelor’s 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.
Responsibilities
- Execute quality assurance activities for new product development within Stryker’s 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 cross-functional 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 non-medical software, including SaMD, MDDS, and AI/ML solutions.
- Implement standard development practices, promoting methodologies like SAFe for mobile and cloud-based 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.
Preferred Qualifications
- Bachelor’s degree in Computer Engineering, Electrical Engineering, Software Engineering, or Computer Science.
- Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601), 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.