Staff Software Quality Engineer
Outset Medical3 hours ago
Base Salary
$155k - $209k/yr
Responsibilities
- Establish, implement, maintain, and objectively evidence software design controls with cross-functional teams.
- Develop software quality assurance strategies, operational plans, testing approaches, verification and validation plans, protocols, reports, and objective evidence.
- Support automated unit and integration testing practices with software development teams.
- Track and analyze customer-reported defects, facilitate root-cause investigations, and support issue resolution.
- Lead or contribute to safety and cybersecurity risk management and product risk-management files.
- Identify quality and quality-system improvements, support CAPA investigations, and drive procedure updates.
- Collect, trend, analyze, and communicate quality data and support regulatory and internal audits.
- Serve as a quality representative and provide technical leadership and mentoring to Quality Engineering and cross-functional team members.
Requirements
- Bachelor’s degree in computer science, engineering science, Electrical Engineering, Software Engineering, or a similar field is required; a master’s degree is preferred.
- At least 7 years of hands-on experience in Design Assurance or Quality Engineering is required.
- Prior medical device experience is required, preferably with capital equipment containing embedded software and/or digital health initiatives.
- Thorough knowledge of FDA Quality System requirements, ISO 13485, ISO 14971, ANSI/AAMI SW96, Good Manufacturing Practices, and applicable quality-system standards.
- Strong leadership, collaboration, influencing, written communication, and verbal communication skills.
- Certified Software Quality Engineer, Certified Quality Engineer, equivalent certification, Lead Auditor certification, Lean certification, and experience with statistical analysis methods or software are preferred.
- Ability to lead initiatives, influence teams, drive continuous improvement, and build relationships with internal and external stakeholders.
Categories
About Outset Medical
Outset Medical builds the Tablo Hemodialysis System, a hardware-and-software dialysis platform with single-use cartridges, for hospitals, dialysis clinics, and home patients. The company generates revenue through capital equipment sales, consumables, and services, and its system is FDA-cleared for use across acute, chronic, and home settings. Headquartered in San Jose, California, Outset Medical is a publicly traded company on NASDAQ.