Design Quality Engineer

Teklabs Inc; California; On-site; USD 90,000 - 130,000; Full time

Job summary

Teklabs Inc. seeks an experienced medical device risk management professional to support design quality, risk analysis, and design controls across Class I–III products. You will develop and maintain risk management files, perform DFMEA/PFMEA/FTA, and collaborate with engineering to ensure regulatory compliance.

Ideal candidates have 3–5 years in medical device risk management, strong ISO knowledge, and excellent communication skills to influence engineering teams throughout product development.

Qualifications

• Bachelor’s degree in Engineering in Mechanical, Biomedical, Electrical, or related field.
• 3–5 years of experience in medical device design quality, design assurance, or risk management.
• Strong working knowledge of ISO 14971, ISO 13485, and QSR/21 CFR Part 820.
• Hands-on experience creating and maintaining risk management files for Class I, II, or III medical devices.
• Proficiency with risk analysis tools (DFMEA, PFMEA, FTA, hazard analysis).
• Experience supporting design controls and product development processes.
• Excellent communication skills and the ability to influence engineering teams.
• Strong analytical and problem-solving abilities.
• Experience with Notified Body audits or FDA inspections is a plus.
• Risk management certification (ISO 14971 lead auditor/lead implementer) is a plus.

Skills

Risk management

ISO 14971 / ISO 13485 / QSR 21 CFR 820

DFMEA

PFMEA

FTA

Hazard analysis

Design controls

Communication skills

Analytical problem solving

Medical device risk management files

Education

Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field)

Tools

DFMEA

PFMEA

FTA

Hazard analysis tools

Job description

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Electrical, or related field).
• 3–5 years of experience in medical device design quality, design assurance, or risk management.
• Strong working knowledge of ISO 14971, ISO 13485, and QSR/21 CFR Part 820.
• Hands‑on experience creating and maintaining risk management files for Class I, II, or III medical devices.
• Proficiency with risk analysis tools (e.g., DFMEA, PFMEA, FTA, hazard analysis).
• Experience supporting design controls and product development processes.
• Excellent communication skills and the ability to influence engineering teams.
• Strong analytical and problem‑solving abilities.

Preferred Qualifications

• Experience with Notified Body audits or FDA inspections.
• Risk management certification (e.g., ISO 14971 lead auditor/lead implementer) is a plus.