Senior Medical Device Quality Engineer — Design & Compliance

Gilero, A Sanner Group Company; Carlsbad (CA); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Annual bonus plan

Medical insurance (BCBS)

Dental and vision

Company-provided life insurance

Short-term and long-term disability

401(k) with company match

LinkedIn learning access

Job summary

Gilero, A Sanner Company is seeking a Senior Design Quality Engineer to oversee quality development of new medical devices and combination products from ideation through transfer to manufacturing. You will guide design teams, ensure ISO 13485 compliance, and drive risk management and verification/validation strategies.

You will work with multiple disciplines to ensure products meet high standards and positively impact patient outcomes globally.

Qualifications

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

Responsibilities

• Represent Quality in cross-functional development teams, providing direction for development through transfer to production activities.
• Author, maintain, and ensure compliance of Design History File documents during the development process in accordance with ISO 13485.
• Translate user needs, regulatory inputs, and risk controls into measurable product requirements, specifications, and acceptance criteria.
• Support design verification and validation activities, including statistical approach and analysis.
• Support manufacturing transfer, including review of preparation and execution of process validation (IQ/OQ/PQ) protocols, and development of production inspection plans.
• Investigate, disposition, and resolve nonconforming material events during product development and pre-production phases.

Skills

Quality management

Regulatory knowledge

Documentation

Communication

Cross-functional teamwork

Problem solving

Office presence

Education

Bachelor's degree in engineering, science, or relevant field

Tools

ISO 13485

FDA 21 CFR 820

Quality systems

Job description

Gilero, A Sanner Company is seeking a Senior Design Quality Engineer to oversee quality development of new medical devices and combination products from ideation through transfer to manufacturing. You will guide design teams, ensure ISO 13485 compliance, and drive risk management and verification/validation strategies.

You will work with multiple disciplines to ensure products meet high standards and positively impact patient outcomes globally.