Senior Quality Engineer (Medical Devices)

TL;DR

Senior Quality Engineer (Medical Devices): Ensuring the quality, reliability, and scalability of single-use products and accessory components for surgical robotics with an accent on NPI, design controls, and regulatory compliance. Focus on executing risk-based design verification and validation, maintaining the Design History File, and driving root cause analysis for V&V failures.

Location: On-site in San Jose, CA. Must be US-based with valid Work Authorization (Citizen or Permanent Resident).

Salary: $126,820 – $149,000 per year

Company

hirify.global is a medical technology company focused on revolutionizing the treatment of benign prostatic hyperplasia (BPH) through innovative surgical robotics.

What you will do

• Lead the planning and execution of design controls, risk management, and design verification/validation (V&V) for new products.
• Develop and maintain the Design History File (DHF) in compliance with QMS and regulatory standards.
• Partner with R&D to define design inputs, outputs, and traceability matrices.
• Spearhead the development of the Risk Management File per ISO 14971.
• Manage the transfer of robust and scalable designs to manufacturing environments.
• Perform root cause analysis on V&V failures and drive NCMRs and CAPA processes.

Requirements

• BS in Engineering, Microbiology, Life Sciences, or a related technical field.
• Minimum 5+ years of experience in the medical device industry (Class II preferred).
• Strong understanding of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR.
• Proficiency in statistical methods and tools such as Minitab.
• Must be a US Citizen or Permanent Resident.
• Experience with surgical instruments or electromechanical devices is highly preferred.

Nice to have

• Master's degree (MS) in a relevant technical field.
• Knowledge of biocompatibility (ISO 10993) and biological risk assessment.
• Experience with reprocessing validations of reusable medical devices.

Culture & Benefits

• Comprehensive health and wellness benefits including full medical coverage.
• Financial security through a 401(k) plan with employer match.
• On-site gym and various wellbeing programs.
• Paid parental leave, flexible or paid time off, and paid holidays.
• Structured career growth through a dedicated management and induction program.