Senior Medical Device Quality Engineer – Design & Risk

Gilero; Chicago, Northern (IL, KY); Hybrid; USD 100,000 - 140,000; Full time

Benefits offered by this job

Annual bonus plan

Medical, dental, and vision insurance

Life insurance

Disability insurance

401(k) with match

LinkedIn Learning access

Job summary

Gilero, a Sanner Company, seeks a Senior Design Quality Engineer for medical devices in Chicago, IL. You will guide quality across design, development, and production with focus on risk management, requirements, and verification/validation strategies to ensure patient safety and regulatory compliance.

This role requires 5+ years of experience, a bachelor’s degree in engineering or science, and strong knowledge of FDA 820 CFRs, ISO 13485, and ISO 14971. Salary range: $100,000–$140,000 annually.

Qualifications

• Bachelor’s degree in engineering or science is required.
• Proven knowledge of medical device quality systems and regulatory requirements.
• Experience applying risk management to device development.

Responsibilities

• Represent Quality in cross-functional development teams and drive transfer to production.
• Author and maintain Design History File documents per ISO 13485.
• Translate user needs and risk controls into measurable requirements and acceptance criteria.
• Support design verification/validation with statistical approaches.
• Lead quality system elements (CAPA, complaints, supplier management, audits).
• Facilitate risk management activities (hazard analysis, FMEAs).
• Ensure traceability of design requirements and risk controls.
• Support manufacturing transfer and process validation protocols.
• Investigate nonconformances and drive CAPA closure.
• Assist in audits and supplier qualification activities.

Skills

Quality management systems

Regulatory knowledge

Risk analysis

Documentation & reporting

Cross-functional collaboration

Auditing

Education

Bachelor's degree in engineering or sciences

Tools

FDA 820 CFRs

ISO 13485

ISO 14971

CGMP

IEC 60601

Job description

Gilero, a Sanner Company, seeks a Senior Design Quality Engineer for medical devices in Chicago, IL. You will guide quality across design, development, and production with focus on risk management, requirements, and verification/validation strategies to ensure patient safety and regulatory compliance.

This role requires 5+ years of experience, a bachelor’s degree in engineering or science, and strong knowledge of FDA 820 CFRs, ISO 13485, and ISO 14971. Salary range: $100,000–$140,000 annually.