Staff Systems Engineer at iRhythm Technologies

San Francisco, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

10+ years of experience in systems engineering or related field, preferably within the medical device industry or similarly regulated environments
Bachelor’s, Master’s, or Ph.D. in Electrical, Biomedical, Systems, or related engineering field
Proven record of shipping regulated electro-mechanical products and contributing to regulatory submissions (e.g., 510k)
Expertise in systems engineering across electrical, mechanical, firmware, and software/cloud interfaces
Demonstrated ability to lead architecture decisions and make clear trade-offs across performance, safety, cost, and schedule
Hands-on familiarity with circuit board schematic/layout, CAD drawings, and laboratory equipment
Proficiency with quality management and requirements/risk management tools (e.g., MasterControl, Jama) and bug tracking (Jira)
Knowledge of FDA regulations and medical device standards: 21 CFR 820, ISO 13485, ISO 14971; familiarity with IEC 60601 and IEC 62304 preferred
Strong written and verbal communication, with a track record of aligning cross-functional teams under ambiguity

Responsibilities

Translate user and business needs into clear system architectures, interfaces, and testable requirements
Own system design and documentation, inclusive of product requirements, system architecture design, technical reports, and trace matrices
Contribute to regulatory submissions, author design history file (DHF) deliverables
Lead post-market investigations, corrective and preventive actions (CAPA), and product improvements
Serve as system architect and decision authority for your product line, balancing safety, performance, cost, and schedule
Mentor engineers and influence across teams without direct authority
Represent Product Development on product core teams and communicate technical trade-offs to leadership and non-technical stakeholders

Skills

Systems Engineering

System Architecture

Requirements Engineering

510k

DHF

CAPA

Trace Matrix

Wearable Devices

Mobile Applications

Cloud Analytics

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

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Mental Health Support

Hybrid Work Options

Pet Insurance

Risks

Increased competition from emerging cardiac monitoring technologies threatens market share.

FDA warning letter may lead to regulatory scrutiny and potential fines.

Shareholder investigation could result in legal challenges and financial liabilities.

Differentiation

Zio Patch offers up to 14 days of uninterrupted cardiac monitoring.

iRhythm's Zio Patch is the smallest and least conspicuous cardiac diagnostic device.

The company provides data analysis services for actionable insights from Zio Patch data.

Upsides

Wearable health tech market growth aligns with iRhythm's business model.

Telehealth expansion increases demand for remote monitoring solutions like Zio Patch.

AI integration enhances arrhythmia detection accuracy in iRhythm's Zio Patch.

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