Manufacturing Engineer

I3 INFOTEK INC; Plano (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

I3 INFOTEK INC is seeking a Manufacturing Engineer with 3–4 years of experience in medical devices manufacturing. You will develop and optimize production processes, validate processes (IQ/OQ/PQ), and contribute to continuous improvement initiatives.

The role requires collaboration across teams in a fast-paced environment, strong communication skills, and adherence to FDA, ISO 13485, and GMP requirements. This position is on-site in Plano, TX.

Qualifications

• Bachelor’s degree in mechanical or manufacturing engineering or equivalent.

Responsibilities

• Develop and optimize manufacturing processes and technologies.

Skills

Manufacturing process development

Lean Manufacturing

Process Validation & FMEA

Root Cause Analysis

Tooling & Equipment design

Design for Manufacturability

Production troubleshooting

Quality systems knowledge

Education

Bachelor’s in mechanical engineering or manufacturing engineering or equivalent

Tools

Minitab

Job description

Qualification: Bachelor’s in mechanical engineering or manufacturing engineering or equivalent

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)