Solutions Engineer

Location: Cypress, CA1 year contract + extensionsOnsite in CypressPay Rate: $40-50/hrAbout iRhythm:iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable biosensing technology with powerful cloud-based data analytics and machine-learning capabilities. Our goal is to be the leading provider of first-line ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm’s continuous ambulatory monitoring has already put over 1 million patients and their doctors on a shorter path to what they both need – answers.About this role:We are seeking a proactive, result-driven and versatile Staff Solutions Engineer to lead strategic technical initiatives across manufacturing operations in a fast-paced, digitally transforming medical device organization. This role sits at the intersection of engineering, digital systems, and operations, combining leadership in project management, requirements engineering, and software validation with a strong commitment to Lean, Agile, and Six Sigma principles to develop and deploy validated, scalable solutions.KEY RESPONSIBILITIESSystems Requirements & Engineering• Lead end-to-end execution of cross-functional operations and engineering projects from scoping and planning through deployment and post-launch support across multiple sites and functions.• Develop project plans, timelines, and resource strategies, risk registers, and project documentation to deliver validated, audit-ready solutions.• Elicit and translate operational, business, and user requirements into functional and technical specifications.• Define architecture, interfaces, and integration points for new and legacy systems, and integrated hardware/software/processes supporting manufacturing operations.Risk & Compliance Management• Conduct and document technical risk assessments (e.g., FMEA, software risk) aligned with ISO 14971.• Ensure system implementations and changes meet ISO 13485, 21 CFR 820/11, and internal operating procedures.Software Validation & Lifecycle Management• Develop and execute validation plans for non-product software used in manufacturing and quality processes.• Collaborate with IT, Systems, QA, and functional owners to ensure validated systems remain compliant through upgrades and change control.About you:Qualifications• Bachelor’s or Master’s degree in Engineering (Systems, Software, or another related technical field).• Experience with developing AWS based solutions and front-end and/or back-end software development a plus.• 3-5 years of experience working in a medical device manufacturing environment, operations engineering, or regulated manufacturing environment.• Strong knowledge of ISO 14971, ISO 13485, 21 CFR Part 11/820, and IEC 62304.• Proven track record delivering validated systems that support production, traceability, and business and compliance objectives.• Demonstrated ability to thrive in rapidly evolving environments with shifting priorities and emerging technologies, and manage multiple priorities within demanding timeframes.• Direct experience in systems V&V related activities within the medical device industry.• Demonstrated experience in project planning, systems integration, and cross-functional technical leadership.