Senior Quality Engineer (Capital Equipment)

TL;DR

Senior Quality Engineer (Capital Equipment): Support new product design transfer through commercialization and design changes for electrical and software systems in surgical robotics devices with an accent on compliance with FDA QSR, ISO 13485, and EU MDR. Focus on risk management via FMEA, establishing validation programs (IQ/OQ/PQ), improving manufacturing processes, and resolving non-conformances through CAPA and root cause analysis.

On-site in San Jose, CA. For US-Based Candidates Only. Work Authorization Status: Citizen / Permanent Resident.

$102,000 - $119,280 a year

Company

hirify.global revolutionizes treatment for benign prostatic hyperplasia (BPH) through innovation in surgical robotics.

What you will do

• Participate in new product design transfer and design changes, focusing on electrical and software systems to ensure quality and reliability.
• Facilitate risk management activities like process FMEA and support design/production release processes.
• Develop inspection, testing strategies, and statistical sampling for electrical assemblies, firmware, and system-level acceptance testing.
• Represent Quality in Capital Equipment Production and Service Operations across the product lifecycle.
• Maintain master validation programs, review manufacturing documentation, and support in-process inspections.
• Audit Device Master Records, ensure training compliance, support regulatory inspections, and drive continuous improvement via failure investigations and CAPA.
• Handle supplier quality issues, MRB decisions, and collaborate on resolutions.

Requirements

• Minimum 5 years experience with Bachelor's or 3 years with Master’s in engineering/scientific discipline (e.g., Biomedical/Electrical)
• 3-5+ years in quality, manufacturing, or engineering in regulated environment (medical device preferred)
• Background in electromechanical and embedded software devices
• Knowledge of FDA QSR CFR820, ISO 13485, ISO 14971, IEC62304
• Detail-oriented with strong communication skills, statistics knowledge, and problem-solving abilities

Nice to have

• Medical Device or Class II device experience
• Experience from other regulated industries (pharmaceutical, military, nuclear)
• EU Medical Device Directive knowledge

Culture & Benefits

• Comprehensive health and wellness benefits including full medical coverage, on-site gym, wellness programs
• 401(k) with employer match, short/long-term disability, life insurance, flexible/PTO, paid parental leave, paid holidays
• Work/life blend culture with pathological optimism, cross-functional team building, and continuous learning opportunities
• Focus on innovation, humility, engagement, and making a difference in patients' lives