Sr Quality Engineer I - Design (Medtech)

TL;DR

Sr Quality Engineer (Medtech): Ensuring the design, development, and lifecycle management of regulated medical devices with an accent on design controls and risk management. Focus on driving robust Design Controls for complex electro-mechanical systems and ensuring compliance with FDA and ISO standards.

Location: Hybrid (Irvine, California). Must be authorized to work in the U.S.; no sponsorship is available.

Salary: $109,000 - $125,000 per year

Company

hirify.global develops innovative diabetes technology, including the Tandem Mobi and t:slim X2 insulin pumps.

What you will do

• Serve as the Design Quality representative for new product development and sustaining engineering projects throughout the lifecycle.
• Lead the execution of Design Controls in compliance with 21 CFR 820.30 and ISO 13485, maintaining the Design History File (DHF).
• Drive risk management activities according to ISO 14971, including hazard analysis and FMEA.
• Ensure traceability between user needs, design inputs, outputs, risks, and validation activities.
• Apply advanced statistical techniques, reliability engineering, and measurement system analysis to define verification strategies.
• Utilize post-market data and complaint trends to inform design improvements and risk reassessments.

Requirements

• Bachelor's degree in Mechanical, Biomedical Engineering, or a related technical field.
• 5+ years of experience as a Quality Engineer in an FDA-regulated industry within design and development.
• Advanced knowledge of Risk Management (ISO 14971) and FDA Quality System Regulation (21 CFR Part 820).
• Proficiency in statistical and analytical techniques, including sampling theory and capability analysis.
• Working knowledge of terminal sterilization modalities (gamma, e-beam, EtO) and sterile packaging systems.
• Ability to interpret mechanical drawings and specifications, including GD&T.

Culture & Benefits

• Comprehensive health care benefits (medical, dental, vision) available from day one.
• Financial security through a 401k plan with company match and an Employee Stock Purchase plan.
• Generous time off including 11 paid holidays and a minimum of 20 days PTO.
• Access to Health Savings Accounts (HSA) and Flexible Saving Accounts (FSA).
• A human-centered culture that encourages innovation and focuses on people first.