Job Description: Manufacturing Engineer
Location: Chennai
Experience: 2 – 5 Years
Industry: Medical Devices
Role Overview
As a Manufacturing Engineer, you will provide critical technical support to the Manufacturing Lead and Senior Technical Manufacturing Lead in bridging the gap between product design and large-scale manufacturing. This role focuses on the execution of process development, equipment validation, and production optimization for medical consumables and electromechanical devices.
Key Responsibilities
Process Development & Technical Execution
- Assist the Senior Lead in executing Design for Manufacturing (DFM) and Design for Assembly (DFA) reviews to ensure seamless product transitions.
- Draft and update comprehensive Standard Operating Procedures (SOPs), manufacturing work instructions, and technical specifications.
- Support the production floor by performing Root Cause Analysis (RCA) using tools like 5-Why or Fishbone diagrams to resolve real-time yield issues and line stoppages.
- Identify opportunities for process improvements and waste reduction through Lean manufacturing principles.
Validation & Quality Compliance
- Draft and execute IQ/OQ/PQ (Installation, Operational, and Performance Qualification) protocols for production equipment and manual/semi-automated assembly lines.
- Participate in PFMEA sessions, taking ownership of technical action items to mitigate identified manufacturing risks.
- Conduct Measurement System Analysis (MSA) and Test Method Validations (TMV) to ensure measurement accuracy and repeatability.
- Maintain accurate documentation within the Device Master Record (DMR) and Design History File (DHF) in strict accordance with ISO 13485 standards.
- Use PLM systems (e.g., Windchill or Teamcenter) for Engineering Change Management and Jira for tracking daily technical tasks and sprint progress.
- Coordinate with external vendors for the fabrication of custom jigs, fixtures, and tooling, ensuring they meet technical requirements.
- Act as a key liaison between the production team and the Senior Technical Lead to ensure project deadlines are met without compromising quality.
Qualifications & Experience
- Education:Bachelor's degree in mechanical, Manufacturing, or Biomedical Engineering.
- Experience:2–5 years of hands-on experience in manufacturing engineering, ideally within Medical Devices or other highly regulated industries (e.g., Automotive, Aerospace).
- Technical Skills:
- Foundational knowledge of ISO 13485 and FDA 21 CFR Part 820.
- Proficiency in 2D/3D CAD software (SolidWorks or AutoCAD).
- Experience with statistical tools (Minitab) and Lean Six Sigma methodologies.
- Experience in Medical Device Consumables or cleanroom manufacturing is a significant advantage.
Benefits
As per Quest company policy
