Sr Solutions Engineer – Manufacturing

United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, ManufacturingIndustries

Requirements

Candidates should possess a Bachelor's degree in Engineering (Industrial, Systems, Software, or another technical related field) and have 4-6 years of experience in a medical device manufacturing, operations engineering, or regulated manufacturing environment. Experience leading cross-functional system implementations and software validation is required, along with familiarity with ISO 13485 and 21 CFR Part 820/11. Lean Six Sigma Green Belt or equivalent experience and SAP experience are preferred.

Responsibilities

The Senior Solutions Engineer will lead medium-to-large projects, ensuring system compliance and supporting digital transformation in a regulated medical device environment. Key responsibilities include gathering and validating functional specifications, acting as a liaison between technical and non-technical teams, supporting SAP implementation, developing system and interface requirements for ERP platforms, managing technical projects from design through post-implementation support, assisting with solution deployment, developing and tracking project plans, coordinating cross-functional efforts, performing PFMEA and software risk analysis, collaborating with QA and compliance teams, leading or supporting validation activities, supporting the development of scalable, validated systems, and leading Lean and Six Sigma projects to improve efficiency and quality.

Skills

Solutions Engineering

Manufacturing

Digital Transformation

Process Engineering

Quality Systems

Compliance

Software Validation

SAP Implementation

ERP Platforms

System Design

Regulatory Needs

Project Management

System Deployment

System Configuration

Testing

Troubleshooting

iRhythm Technologies

Advanced cardiac monitoring solutions provider

About iRhythm Technologies

iRhythm Technologies focuses on cardiac monitoring solutions, with its main product being the Zio Patch, a wearable device that tracks heart rhythms for up to 14 days. This extended monitoring helps healthcare providers detect irregular heart rhythms that shorter monitoring might miss, making it especially useful for patients at risk. The company serves both patients and healthcare providers, generating revenue by selling the Zio Patch and offering data analysis services to interpret the collected heart data. iRhythm aims to improve patient outcomes and streamline healthcare workflows in the cardiac health sector.

San Francisco, CaliforniaHeadquarters

2006Year Founded

$102.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees