Solutions Engineer
Listed on 2026-08-09
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Manufacturing / Production
Regulatory Compliance Specialist, Systems Engineer
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 RESPONSIBILITIES Systems 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.
- 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.
- 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 time frames.
- 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.
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