Staff Software Quality Engineer
Staff Software Quality Engineer
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$ 136490 - 175000
1 Vacancy
Job Description
Boldly innovating to create trusted solutions that detect predict and prevent disease.
Discover your power to innovate while making a difference in patients lives.iRhythm is advancing cardiac careJoin Us Now!
At iRhythm we are dedicated selfmotivated and driven to do the right thing for our patients clinicians and coworkers. Our leadership is focused and committed to iRhythms employees and the mission of the company. We are better together embrace change and help one another. We are Thinking Bigger and Moving Faster.
Position: Staff Software Quality Engineer
Location: 6550 Katella Ave Cypress CA 90630
Responsibilities include:
iRhythm Technologies Inc. is looking for an experienced Staff Software Quality Engineer (Cypress CA) within the New Product Introduction Quality Engineering group to drive software quality engineering support to iRhythms development and manufacturing environments. The scope of this role includes supporting manufacturing software systems and processes within manufacturing. This individual will work closely with the Product Development and Manufacturing Engineering teams in process automation development. Provide critical Validation Engineering and quality driven input towards the early phase of new product introductions/projects. Provide QA guidance throughout the development of Software based User Requirements and specifications. Participate in the oversite for IQ/OQ/PQs TMVs engineering studies and software validations. Support development of Product Firmware NonProduct Software peripheral software (Databases MES ERP) and systems needs with development teams as it relates to manufacturing systems. Apply statistical knowledge to complete and analyze datasets interpret results and provide data driven feedback to design and manufacturing teams. Work with cross functional teams to improve efficiencies across the manufacturing floor. Develop and continuously improve Quality procedures to ensure compliance with applicable standards and industry practices. Produce technical reports to support Quality Assurance investigations as needed. 10 domestic travel required.
SALARY: $136490 to $175000 per year
JOB REQUIREMENTS:
Requires Masters degree in Electrical Engineering Biomedical Engineering Computer Science Engineering or related field and 6 years of Quality Assurance experience within a manufacturing environment. In the alternative employer will accept a Bachelors degree in the mentioned fields and 8 years of specified experience. Must have experience with: FDA regulations including 21 CFR 820 ISO 13485 and ISO 14971; Standards and Regulations including GxP regulations and CSV/CSA principles 21 CFR Part 11 Electronic Records Electronic Signatures GAMP 5 and Software development lifecycle (SDLC); Endtoend manufacturing processes including assemblies secondary packaging and subassembly processes; SDLC including design of SaMD and nonproduct software; Working with embedded systems; Highlevel language such as C# VB and Python; Software systems on a manufacturing systems such as SCADA andMES; Developing V&V strategy and planning for Non product SW; Using Microsoft Excel Word and Visio; and Root cause analysis. 10 domestic travel required.
THIS POSITION IS ELIGIBLE FOR THE EMPLOYEE REFERRAL PROGRAM
Actual compensation may vary depending on jobrelated factors including knowledge skills experience and work location.
As a part of our core values we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds experiences skills and perspectives. iRhythm Technologies Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws.
iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures including those who may have any difficulty using our online system. If you need such an accommodation you may contact us at
About iRhythm Technologies
iRhythm is a leading digital healthcare company that creates trusted solutions that detect predict and prevent disease. Combining wearable biosensors and cloudbased data analytics with powerful proprietary algorithms iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care iRhythms vision is to deliver better data better insights and better health for all.
Make iRhythm your path forward. Zio the heart monitor that changed the game.
Required Experience:
Staff IC
Employment Type
Full-Time
