Senior Software Quality Assurance Engineer I

United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Healthcare Technology, BiotechnologyIndustries

Requirements

Candidates must possess a Bachelor's degree in a technical discipline and have over 7 years of software QA experience, with at least 3 years in medical device or FDA-regulated software development. They should demonstrate ownership of DHF deliverables, including test plans, protocols, reports, and traceability matrices, and have a strong understanding of design control procedures and the software development lifecycle in regulated environments. Experience supporting regulatory submissions and audits, excellent analytical and problem-solving skills, and the ability to work independently are essential. Proven mentoring experience with junior QA team members, effective written and verbal communication skills, strong attention to detail, and hands-on experience with MySQL, Linux, and Agile environments are also required. The ability to quickly learn new tools, applications, and technologies is necessary.

Responsibilities

The Senior Software QA Engineer will own the design and execution of verification strategies, including test plans, protocols, reports, and traceability matrices, in compliance with FDA, IEC 62304, and ISO 13485 requirements. They will review and contribute to requirements and design documentation, provide cross-functional support for new product introductions and software releases, and prepare SQA documentation for regulatory submissions. Responsibilities include defining test strategies and effort estimates, working with databases, APIs, and Linux environments for validation, and supporting end-to-end integration testing. The role involves analyzing and testing production issues, driving root cause investigations, collaborating with Agile teams, contributing to DHF activities, mentoring junior QA engineers, and championing quality best practices. Additionally, they will partner with test automation engineers to identify and implement automation opportunities.

Skills

Software Quality Assurance

Verification

Test Plans

Test Protocols

Traceability Matrices

FDA

IEC 62304

ISO 13485

Requirements Analysis

Design Documentation

Risk Assessment

Databases

APIs

Linux

Data Integrity

System Behavior

Workflow Validation

Mentoring

iRhythm Technologies

Advanced cardiac monitoring solutions provider

About iRhythm Technologies

iRhythm Technologies focuses on cardiac monitoring solutions, with its main product being the Zio Patch, a wearable device that tracks heart rhythms for up to 14 days. This extended monitoring helps healthcare providers detect irregular heart rhythms that shorter monitoring might miss, making it especially useful for patients at risk. The company serves both patients and healthcare providers, generating revenue by selling the Zio Patch and offering data analysis services to interpret the collected heart data. iRhythm aims to improve patient outcomes and streamline healthcare workflows in the cardiac health sector.

San Francisco, CaliforniaHeadquarters

2006Year Founded

$102.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees