Senior Software Quality Assurance Engineer
$140,000–$150,000 year
Remote · Redwood City, California, United States or United States
Redwood City, California, United States or United StatesRemoteFull Time$140,000–$150,000 yearSenior LevelBachelors DegreeUnknown
Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Unknown
Job Summary
Senior Software Quality Assurance Engineer position at Element Science, Inc., focusing on medical device software quality practices. Requires a Bachelor's degree and 7+ years of experience in the medical device industry.
Required Qualifications
- Bachelor's degree in Computer Science, Software Engineering, or related field, or equivalent experience
- A minimum of 7+ years of recent medical device experience
- Experience writing and executing validation/verification plans, protocols, and software risk analysis on Medical Devices
- Medical Device experience covering embedded software
- Strong cross-functional communication skills
- Strong written skills to define and document V&V outputs
- Experience in Threat Modeling and Software Risks
- Working knowledge of FDA, Software Validation Guidance, 21 CFR part 820, IEC 62304, and IEC 82304-1
- Excellent written and verbal communication skills
Desired Qualifications
- Experience with scripting or programming (Python, C, or similar)
- Experience in automation frameworks
- Knowledge of software quality and regulatory compliance (ISO 13485, IEC 62304) is a plus
Additional Requirements
- We are not able to sponsor individuals for employment visas for this job
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