Sr Quality Engineer I (Hardware)

TL;DR

Sr Quality Engineer I (Hardware) (Medtech): Ensuring the design, development, and lifecycle management of regulated medical devices with an accent on regulatory compliance, reliability, and patient safety. Focus on driving robust Design Controls and Risk Management for complex electro-mechanical systems and consumables.

Location: Hybrid (Del Mar, CA) - Must be in office 2 days per week

Salary: $108,000 - $120,000

Company

hirify.global creates innovative insulin delivery systems, such as the Tandem Mobi and t:slim X2, to improve the lives of people with diabetes.

What you will do

• Serve as the Design Quality representative for new product development and sustaining engineering projects.
• Lead the execution of Design Controls in compliance with 21 CFR 820.30, ISO 13485, and global regulations.
• Drive risk management activities per ISO 14971, including hazard analysis and FMEA.
• Review and approve design changes, verification, and validation (V&V) activities.
• Apply advanced statistical techniques to evaluate design margins and process capability.
• Support internal and external audits, including FDA and notified body inspections.

Requirements

• Bachelor’s degree in a technical field (Mechanical Engineering preferred).
• 5+ years of experience as a Quality Engineer in an FDA-regulated hardware or medical device environment.
• In-depth knowledge of 21 CFR Part 820 and ISO 13485.
• Advanced understanding of Risk Management per ISO 14971.
• Must be based in or able to work hybrid in Del Mar, CA.
• Proficiency in statistical analysis, sampling theory, and test method validation.

Nice to have

• Experience working in an ISO environment.
• Familiarity with terminal sterilization modalities (gamma, e-beam, EtO).
• Knowledge of GD&T and medical device manufacturing/assembly technologies.
• Understanding of supplier quality within a design controls framework.

Culture & Benefits

• Comprehensive healthcare (medical, dental, vision) available from day one.
• 401k plan with company match and Employee Stock Purchase plan.
• Generous paid time off (minimum 20 days) and 11 paid holidays per year.
• Health Savings Accounts (HSA) and Flexible Saving Accounts (FSA).
• Inclusive work environment that celebrates diversity and well-being.