Medical Device Mfg Engineer — Process Validation & DFM

International Association of Plumbing and Mechanical Officials (IAPMO); Plano, Northern (TX, KY); Hybrid; USD 80,000 - 110,000; Full time

Job summary

International Association of Plumbing and Mechanical Officials (IAPMO) is seeking a Manufacturing Engineer with 3–4 years of experience in medical device manufacturing. The role focuses on developing and validating manufacturing processes, performing PFMEAs, and driving data-based improvements.

Candidates should be proficient in process validation (IQ/OQ/PQ), design for manufacturability, and quality systems aligned with FDA/ISO 13485 GMP standards.

Qualifications

• Minimum 3–4 years in Medical devices manufacturing engineering.
• Experience with IQ/OQ/PQ process validations.
• Experience in process development and characterization.
• Experience with PFMEAs.
• Data analysis using Minitab.
• Familiar with FDA/ISO 13485, GMP quality systems.

Skills

Manufacturing process development

Process validations

Process characterization

PFMEA

Data analysis

DFM

Production troubleshooting

Quality systems knowledge

Job description

International Association of Plumbing and Mechanical Officials (IAPMO) is seeking a Manufacturing Engineer with 3–4 years of experience in medical device manufacturing. The role focuses on developing and validating manufacturing processes, performing PFMEAs, and driving data-based improvements.

Candidates should be proficient in process validation (IQ/OQ/PQ), design for manufacturability, and quality systems aligned with FDA/ISO 13485 GMP standards.