Manufacturing Engineer

International Association of Plumbing and Mechanical Officials (IAPMO); Plano, Northern (TX, KY); On-site; 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

Minimum experience of 3-4 years in Medical devices - Manufacturing Engineering.

• Good Experience working on Process Validations (IQ, OQ, PQ)
• Experience developing manufacturing processes and technologies, which includes process characterization
• Experience working on PFMEAs
• Experience performing Data analysis (Minitab)
• Evaluate process and design alternatives based on Design for Manufacturability principles.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Skill:

• 1. Manufacturing process development and optimization
• 2. Lean Manufacturing and Continuous Improvement
• 3. Process Validation and FMEA (Failure Mode & Effects Analysis)
• 4. Root Cause Analysis and Problem Solving
• 5. Tooling, fixture, and equipment design
• 6. Design for Manufacturability (DFM)
• 7. Production troubleshooting and equipment support
• 8. Quality systems knowledge (FDA, ISO 13485, GMP)