Staff Software Quality Engineer

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 iRhythm's 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 execution oversite for IQ/OQ/PQs, TMVs, engineering studies, and software validations. Support development of Product Firmware, Non-Product 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: $136,490 to $175,000 per year

JOB REQUIREMENTS:

Requires Master's 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 Bachelor's 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); End-to-end manufacturing processes, including assemblies, secondary packaging, and sub-assembly processes; SDLC including design of SaMD and non-product software; Working with embedded systems; High-level 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