Senior Medical Device Design Quality Engineer

Gilero; Carlsbad (CA); Hybrid; USD 100,000 - 140,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental insurance

Vision insurance

401(k) matching

Professional development

Job summary

Gilero, a Sanner Company, is hiring a Senior Design Quality Engineer in Carlsbad, CA. You will oversee quality development of medical devices and combination products from ideation through transfer to manufacturing, focusing on risk mitigation, requirements, and verification/validation strategies.

The role requires FDA 820 CFRs and ISO 13485 expertise, with 5+ years in a medical device environment. You will engage in cross-functional teams, audits, and supplier quality activities to ensure

Qualifications

• Bachelor's degree in engineering, science, or relevant field.
• 5+ years relevant work experience.
• Proficiency with FDA 820 CFRs/ISO 13485/cGMP quality management systems for medical devices.
• Proficiency with ISO 14971 and risk management for medical devices.

Responsibilities

• Represent Quality in cross-functional development teams, guiding from development through transfer to production.
• Maintain and ensure Design History File compliance per ISO 13485.
• Translate user needs and regulatory inputs into measurable requirements and acceptance criteria.
• Support design verification/validation including statistical approaches.
• Facilitate risk management activities (hazard analysis, FMEAs, ISO 14971).
• Assist in design transfer and process validation protocols (IQ/OQ/PQ).
• Investigate and disposition nonconformances; support production during transfers.

Skills

Quality management

Regulatory compliance

Risk management

Communication

Cross-functional collaboration

Project management

GxP experience

Education

Bachelor's degree in engineering or sciences

Tools

ISO 13485

ISO 14971

FDA 21 CFR 820

IEC 60601

Job description

Gilero, a Sanner Company, is hiring a Senior Design Quality Engineer in Carlsbad, CA. You will oversee quality development of medical devices and combination products from ideation through transfer to manufacturing, focusing on risk mitigation, requirements, and verification/validation strategies.

The role requires FDA 820 CFRs and ISO 13485 expertise, with 5+ years in a medical device environment. You will engage in cross-functional teams, audits, and supplier quality activities to ensure