Senior CSV Engineer (Non-Product Systems)
: Job Details :

iRhythm Technologies, Inc. provided pay range

This range is provided by iRhythm Technologies, Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$112,000.00/yr - $145,000.00/yr

About the Role:

As a Senior Quality Engineer – Computer System Validation (CSV), you'll support validation and compliance efforts for non-product computerized systems used across manufacturing, quality, and business operations at iRhythm. You'll ensure these systems meet regulatory standards such as FDA 21 CFR Part 11/820, ISO 13485, and EU MDR.

This hybrid, full-time role is based in Cypress, CA, with 3 in-office days per week.

Key Responsibilities:

• Lead validation activities for GxP-relevant non-product systems.
• Ensure compliance with FDA, ISO, and EU requirements across the software lifecycle.
• Collaborate with IT, QA, and vendors to manage system validation and change controls.
• Review and approve validation deliverables (e.g., plans, protocols, reports).
• Maintain system inventory and documentation per retention policies.
• Support audits and inspections with CSV expertise.
• Promote data integrity and compliance with Part 11/Annex 11 standards.

About You:

• Bachelor's in Engineering, Computer Science, Life Sciences, or related field.
• 5+ years in CSV/software assurance in medical device, pharma, or biotech.
• Strong knowledge of regulatory frameworks and GAMP5 guidelines.
• Experience with QMS/ERP systems (e.g., MasterControl, Veeva, SAP).
• Skilled in SDLC, cloud/on-premise systems validation, and audit readiness.
• Organized, detail-oriented, and capable of managing multiple projects.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesMedical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

Referrals increase your chances of interviewing at iRhythm Technologies, Inc. by 2x

Sign in to set job alerts for “Product Engineer” roles.

Brea, CA $84,000.00-$101,000.00 1 week ago

Irvine, CA $125,000.00-$169,800.00 1 week ago

Orange, CA $80,000.00-$100,000.00 21 hours ago

Irvine, CA $85,400.00-$94,900.00 2 weeks ago

Huntington Beach, CA $90,000.00-$160,000.00 3 months ago

Irvine, CA $175,000.00-$200,000.00 2 weeks ago

Anaheim, CA $90,000.00-$110,000.00 17 hours ago

Sr Mechanical Design Engineer - Consumer Goods

Irvine, CA $120,000.00-$150,000.00 1 day ago

Lake Forest, CA $70,000.00-$95,000.00 2 days ago

Irvine, CA $95,825.00-$117,120.00 1 week ago

Irvine, CA $119,076.00-$145,537.00 2 weeks ago

Manufacturing Engineer - New Product Introduction (NPI)

Fullerton, CA $90,000.00-$115,000.00 3 weeks ago

Placentia, CA $90,000.00-$115,000.00 3 weeks ago

Orange, CA $90,000.00-$115,000.00 3 weeks ago

Quality Engineer/Aerospace ManufacturingSr. Mechanical Design & Release Engineer - Wheels

Irvine, CA $107,000.00-$134,800.00 1 day ago

Santa Ana, CA $90,000.00-$115,000.00 3 weeks ago

Manufacturing Engineer, EOL & Electrical DiagnosisSenior Vehicle Accessory Product Development Engineer

Irvine, CA $176,200.00-$220,300.00 1 week ago

Irvine, CA $90,000.00-$120,000.00 12 hours ago

Irvine, CA $95,000.00-$180,000.00 1 week ago

Santa Ana, CA $75,000.00-$110,000.00 2 weeks ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr