Senior Medical Device Design Quality Engineer

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

Benefits offered by this job

Annual bonus

Medical, dental, vision coverage

Company-provided life insurance

Short-term and long-term disability

401(k) with company match

LinkedIn Learning access

Job summary

Gilero, a Sanner Group Company, seeks a Senior Design Quality Engineer in Chicago to drive quality during the design, development, and transfer of medical devices and combination products. You will guide risk mitigation, define requirements, and shape verification/validation strategies to meet stringent regulatory standards.

You will collaborate across disciplines to ensure products meet patient safety and performance goals, while supporting audits, CAPA, and supplier quality activities in a

Qualifications

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

Responsibilities

• Represent Quality in cross-functional development teams from design through transfer to production.
• Author and maintain Design History File documents per ISO 13485.
• Translate user needs, regulatory inputs, and risk controls into measurable product requirements and acceptance criteria.
• Support design verification and validation activities, including statistical approaches.
• Assist with quality system elements (CAPA, complaints, supplier management, audits).
• Lead risk management activities per ISO 14971 and ensure traceability of requirements and controls.
• Support manufacturing transfer, including review of IQ/OQ/PQ protocols and inspection plans.
• Investigate nonconforming material events and support production as needed.
• Act as technical expert for new or revised QMS procedures and training.
• Support internal and external audits with the quality team.
• Support supplier qualification and ongoing monitoring.

Skills

Quality systems knowledge

Regulatory compliance (FDA 820 / ISO 庆

Risk management (ISO 14971)

Medical device development

Electromechanical devices

Written and verbal communication

Cross-functional collaboration

Education

Bachelor's degree in engineering/science

Job description

Gilero, a Sanner Group Company, seeks a Senior Design Quality Engineer in Chicago to drive quality during the design, development, and transfer of medical devices and combination products. You will guide risk mitigation, define requirements, and shape verification/validation strategies to meet stringent regulatory standards.

You will collaborate across disciplines to ensure products meet patient safety and performance goals, while supporting audits, CAPA, and supplier quality activities in a