Senior Design Quality Engineer (Medtech)

TL;DR

Senior Design Quality Engineer (Medtech): Direct contribution to the design and quality of life-saving Neurovascular devices with an accent on risk management, reliability studies, and V&V activities. Focus on integrating quality engineering into new product development, applying DOE, and ensuring compliance with FDA and ISO standards.

Location: Must be based in Irvine, CA (minimum 4 days a week onsite)

Salary: $107,200 - $160,800 USD

Company

Global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life.

What you will do

• Collaborate with R&D and Process Development to influence the design of cutting-edge medical devices.
• Conduct technical reliability studies, design of experiments (DOE), and apply Design for Manufacturability principles.
• Manage risk throughout the product lifecycle using risk management tools and analysis studies.
• Compile and analyze performance reports and process control statistics to improve system reliability.
• Oversee Validation & Verification (V&V) activities and serve as a Core Reliability/Quality Engineer for R&D programs.
• Mentor junior engineers and contribute to a culture of professional growth.

Requirements

• Bachelor's degree in Engineering or Science.
• Minimum 4 years of experience in Engineering and/or Quality (or advanced degree with 2+ years).
• Must possess unrestricted U.S. work authorization at the time of hire.
• Ability to travel up to 25% (domestic and international).

Nice to have

• Experience with Vascular or Neurovascular devices.
• Proficiency in Advanced Statistics, Minitab, DOE, and capability analysis.
• Knowledge of ISO 13485, EU MDR, and FDA QSR standards.
• Certification from ASQ or experience with Six Sigma/LEAN methodologies.
• Expertise in DRM, Metals, or Polymers testing.

Culture & Benefits

• Competitive salary and the hirify.global Incentive Plan (MIP).
• Comprehensive health, dental, and vision insurance, including HSA and FSA.
• 401(k) plan with employer contribution and match.
• Paid time off, paid holidays, and short-term disability.
• Employee Stock Purchase Plan and tuition reimbursement.
• Global well-being program "Simple Steps".