Sr Solutions Engineer – Manufacturing

About iRhythm

Career-defining. Life-changing. At iRhythm, you’ll have the opportunity to grow your skills and your career while impacting the lives of people around the world. iRhythm is shaping a future where everyone, everywhere can access the best possible cardiac health solutions. Every day, we collaborate, create, and constantly reimagine what’s possible. We think big and move fast, driven by our commitment to put patients first and improve lives. We need builders like you. Curious and innovative problem solvers looking for the chance to meaningfully shape the future of cardiac health, our company, and your career.

About This Role

We are seeking a technically skilled and quality-focused Senior Solutions Engineer who will play a critical role in delivering validated digital and process solutions across manufacturing operations. This role leads medium-to-large projects, ensures system compliance, and supports ongoing improvement in support of digital transformation in a regulated medical device environment. The ideal candidate combines expertise in systems and process engineering with a strong understanding of quality systems, compliance, and software validation, supporting initiatives that drive operational excellence, regulatory readiness, and continuous improvement.

KEY RESPONSIBILITIES

• Collaborate with users and stakeholders to gather, refine, and validate functional specs.
• Act as a bridge between technical teams (e.g., developers, IT) and non-technical internal stakeholders, translating complex technical concepts into clear, actionable plans.
• Support organizational SAP Implementation.
• Develop system and interface requirements for ERP platforms.
• Ensure alignment of system design with regulatory and operational needs.
• Manage technical projects from design through deployment and post-implementation support.
• Assist with the deployment of solutions, including configuring systems, testing for compatibility, and troubleshooting issues.
• Develop and track project plans, risks, and milestones.
• Coordinate cross-functional efforts across engineering, quality, Systems, IT, and operations.
• Perform PFMEA, and software risk analysis.
• Collaborate with QA and compliance teams to ensure risk mitigations are implemented and verified.
• Lead or support validation activities including test plan creation and execution.
• Support development of scalable, validated systems.
• Lead Lean and Six Sigma projects to improve efficiency, reduce waste, and increase quality performance.
• Support KPI development and monitoring for manufacturing and quality systems.

About You

Qualifications

• Bachelor’s in Engineering (Industrial, Systems, Software, or another technical related).
• 4–6 years of experience working in a medical device manufacturing environment, operations engineering, or regulated manufacturing environment.
• Experience leading cross-functional system implementations and software validation.
• Familiarity with ISO 13485, and 21 CFR Part 820/11.

Preferred Skills

• Lean Six Sigma Green Belt or equivalent experience.
• Experience with SAP a plus.
• Knowledge of Agile project management tools (Jira, Smartsheet, etc.).

Employment Type

Full time

Location

Remote - US

Compensation

Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location. Estimated Pay Range: $96,000.00 - $125,000.00

Diversity & Inclusion

As part of our core values, we ensure an 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 taops@irhythmtech.com