Senior Durham Medical Device Design Quality Engineer

Gilero; Durham, Northern (NC, KY); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Annual bonus plan

Medical insurance

Dental and vision

Life insurance

Disability insurance

401(k) with company match

LinkedIn Learning access

Job summary

Gilero, a Sanner Company, is seeking a Senior Design Quality Engineer in Durham, NC to drive quality activities from the design phase through production transfer. You will ensure design controls, risk management, and verification/validation strategies meet medical device requirements.

The role requires 5+ years of experience with FDA 820 CFRs, ISO 13485, cGMP, and a strong quality mindset. On-site collaboration across disciplines will be essential to deliver safe, compliant, and high-quality

Qualifications

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

Responsibilities

• Represent Quality in cross-functional development teams and oversee transfer to production.
• Author and maintain Design History File documents per ISO 13485.
• Translate user needs and regulatory inputs into measurable product requirements and acceptance criteria.
• Support design verification and validation activities and risk management per ISO 14971.
• Participate in CAPA, supplier management, internal/external audits, and change control.

Skills

5+ years experience

Cross-functional collaboration

Quality system knowledge

Risk management

Education

Bachelor's degree in engineering/science

Job description

Gilero, a Sanner Company, is seeking a Senior Design Quality Engineer in Durham, NC to drive quality activities from the design phase through production transfer. You will ensure design controls, risk management, and verification/validation strategies meet medical device requirements.

The role requires 5+ years of experience with FDA 820 CFRs, ISO 13485, cGMP, and a strong quality mindset. On-site collaboration across disciplines will be essential to deliver safe, compliant, and high-quality