Stefanini is looking for Principal Software Quality Engineer in Bellevue, WA (Hybrid)
For quick Apply, please reach out to Somnath Ghosh- call: 2489365051 / email: somnath.ghosh@stefanini.com
Work Hours: M-F (40 hours)
Work Location: Bellevue, WA (Hybrid) Local candidate preferred.
Shift: 1st Shift (8:00 AM – 5:00 PM PST)
8+ years of progressive Quality Engineering experience in the Medical Device industry with hands-on support for hardware and software development.
Responsibilities:
Provide Quality Engineering leadership for software and hardware product development teams. Responsible for leading design control, risk management, and other Quality Engineering activities for new product development projects.
Establish and nurture strong relationships with cross-functional product development team members to optimize success of development projects.
Lead the development and maintenance of the Risk Management File (RMF) including risk management plans, hazards analysis, dFMEA, pFMEAs, and risk management report.
Provide Quality Engineering input, review, and approval of the Design History File (DHF) and associated documentation. Responsible for quality oversight and approval of product development plans, design inputs and outputs, verification and validation, and review of test planning, protocols, and reports.
Provide guidance on statistical methods and analyses for design verification and validation, including test method validation.
Serve as the SME for software quality and collaborate with teams on code reviews, software security analysis, and the software BOM; lead implementation of best practices for software quality processes.
Participate in design reviews to ensure the effective development, transfer, and maintenance of the product (hardware and software) throughout the product lifecycle.
Support the successful transfer and hyper-care phase of design and design modifications into production / field deployment.
Provide Quality Engineering support for anomalies (e.g., software bugs, cybersecurity vulnerabilities, etc.) encountered in production and development projects. Guide triage and remediation efforts.
Secondary/Backup Duties and Responsibilities:
Lead changes to the Quality System based on new regulations, guidance documents, industry standards, and observations.
Own the resolution and timely closure of CAPAs as they relate to the design control process.
Provide Quality Engineering support for released products, interfacing with customer support representatives and account executives as necessary.
Support other areas of the Quality System and perform other tasks as defined by Management.