MedDev Manufacturing Engineer I - Plano, TX 75024

Job Title: Manufacturing Engineer I

Location: Plano, TX

Duration: 04 Months

Supplier Call Notes:

• • Will Support Production Issues
  • Will Support Investigations & Reporting
  • Support New equipment implementations
  • Root Cause Analysis/6M
  • Troubleshooting
  • Monitoring
  • Documentation
  • Cross functional Collaboration
  • English Fluency
  • Medical Device is Nice to have - Regulated Industry will also work
  • Internship will also work
  • 0-3 Years with Bachelors (Mechanical Eng. preferred)

Job Overview

We are seeking a detail-oriented and motivated Manufacturing Engineer I to support our daily manufacturing operations and drive continuous improvement initiatives. In this role, you will troubleshoot production issues, analyze yield and defect data, and lead root cause investigations. You will also play a key role in implementing and validating new equipment and processes using the IQ/OQ/PQ framework within a regulated environment.

Working closely with cross-functional partners across Quality, Production, and R&D, you will ensure our manufacturing operations remain compliant, efficient, and aligned with industry standards.

Key Responsibilities

Manufacturing Support & Troubleshooting: Identify, troubleshoot, and resolve daily equipment and manufacturing line issues to minimize downtime.

Process Optimization & Yield Analysis: Monitor and analyze key performance metrics, yield data, scrap, and defect rates to drive continuous improvement initiatives.

Root Cause Analysis: Independently perform in-depth root cause investigations using structured methodologies (e.g., 6M, 5-Why) and implement effective corrective actions.

Process Validation (IQ/OQ/PQ): Support the installation, operation, and performance qualification of new manufacturing equipment, automation, and processes.

Quality & Regulatory Compliance: Document technical findings, procedures, and validation protocols in strict accordance with FDA regulations and ISO standards.

Cross-Functional Collaboration & Reporting: Partner closely with Quality, Production, and R&D teams. Clear, effective presentation of activity status, technical findings, and project milestones to stakeholders across multiple organizational levels.

Core Qualifications

Requirements

Education: Bachelor s degree in Engineering (Mechanical Engineering strongly preferred; Industrial, Electrical, Chemical, or Bioengineering also accepted).

Experience: 0 to 3 years of relevant experience in a manufacturing or engineering environment.

Language & Communication: Native or fluent English language skills (written and spoken) for technical documentation, cross-functional collaboration, and daily meetings.

Interpersonal Skills: Proven ability to influence, communicate, and collaborate effectively with diverse cross-functional groups across all levels of the organization.

Top Skills & Competencies

Technical Problem-Solving: Ability to evaluate mechanical and process challenges and develop practical solutions.

Data Analysis: Proficiency in tracking process metrics, yield rates, scrap data, and production trends.

Structured RCA: Practical application of root-cause analysis tools (5 Whys, 6M/Fishbone diagrams).

Attention to Detail: High precision in documentation and procedural execution within regulated environments.

Preferred Experience & Skills

Internship or co-op experience in a regulated manufacturing setting (e.g., Medical Devices or Pharmaceuticals).

Exposure to Lean Manufacturing or Six Sigma methodologies.

Familiarity with statistical analysis tools (e.g., Minitab, JMP).

Experience navigating ERP or MES systems.

Hands-on exposure to equipment installation, commissioning, or automation systems.