Sr Solutions Engineer – Manufacturing
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.).
Location:
Remote - US
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
As a 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
About iRhythm Technologies iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s 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.
There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact taops@irhythmtech.com. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.
For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121
About the job
Apply for this position
Sr Solutions Engineer – Manufacturing
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.).
Location:
Remote - US
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
As a 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
About iRhythm Technologies iRhythm is a leading digital healthcare company that creates trusted solutions that detect, predict, and prevent disease. Combining wearable biosensors and cloud-based data analytics with powerful proprietary algorithms, iRhythm distills data from millions of heartbeats into clinically actionable information. Through a relentless focus on patient care, iRhythm’s 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.
There have been instances where individuals not associated with iRhythm have impersonated iRhythm employees pretending to be involved in the iRhythm recruiting process, or created postings for positions that do not exist. Please note that all open positions will always be shown here on the iRhythm Careers page, and all communications regarding the application, interview and hiring process will come from a @irhythmtech.com email address. Please check any communications to be sure they come directly from @irhythmtech.com email address. If you believe you have been the victim of an imposter or want to confirm that the person you are communicating with is legitimate, please contact taops@irhythmtech.com. Written offers of employment will be extended in a formal offer letter from an @irhythmtech.com email address ONLY.
For more information, see https://www.ftc.gov/business-guidance/blog/2023/01/taking-ploy-out-employment-scams and https://www.ic3.gov/Media/Y2020/PSA200121