Manufacturing Engineering Lead

Quest Global; Chennai District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Quest Global in Chennai District is seeking a Manufacturing Engineering Lead. This role involves supporting the Senior Technical Manufacturing Lead in transitioning medical devices to production. You will execute process improvements, develop protocols, and maintain documentation.

Ideal candidates will have a Bachelor’s degree in Mechanical, Manufacturing, or Biomedical Engineering, along with 6–12 years of experience in manufacturing engineering, particularly within the Medical Device sector.

Benefits are in accordance with company policy.

Qualifications

• 6–12 years professional experience in manufacturing engineering.
• Experience in medical device or regulated sectors like Aerospace or Automotive.
• Proven track record of leading projects and driving continuous improvement.

Responsibilities

• Execute process improvements under the guidance of the Senior Lead.
• Collaborate with design teams using DFM and DFA principles.
• Create and maintain detailed manufacturing work instructions.

Skills

Process improvements

Root Cause Analysis (RCA)

Design for Manufacturing (DFM)

ISO 13485 compliance

Education

Bachelor’s degree in Mechanical, Manufacturing, or Biomedical Engineering

Tools

PLM tools (Windchill/Teamcenter)

Jira

Job description

Role Overview

As a Manufacturing Engineering Lead, you will be the technical pivot supporting the Senior Technical Manufacturing Lead in transitioning medical consumables and electromechanical devices from design to full‑scale production. You will be responsible for hands‑on execution of process development, validation protocols, and technical documentation.

Key Responsibilities

• Execute process improvements to enhance production efficiency under guidance of the Senior Lead.
• Collaborate with design teams applying Design for Manufacturing (DFM) and Design for Assembly (DFA) principles to optimize new products for high‑volume production.
• Create and maintain detailed manufacturing work instructions, SOPs, and technical specifications.
• Perform Root Cause Analysis (RCA) on production line failures or yield issues using tools such as 8D and Fishbone, implementing corrective actions to prevent recurrence.
• Develop and execute Installation, Operational, and Performance Qualification protocols (IQ/OQ/PQ) for new equipment and automated assembly lines.
• Facilitate PFMEA sessions to identify potential failure modes and execute the technical mitigation tasks required to lower risk profiles.
• Conduct Measurement System Analysis (MSA) and Test Method Validations (TMV) to ensure gauge R&R meets stringent medical standards.
• Ensure all activities align with ISO 13485 and IEC 60601‑1; maintain the integrity of the Device Master Record (DMR) and Design History File (DHF).
• Utilize PLM tools (Windchill/Teamcenter) for change management and Jira for daily technical task tracking and sprint updates.
• Work closely with tooling and equipment vendors to ensure custom fixtures and molds meet technical specifications and delivery timelines.
• Serve as the technical bridge between the production floor, quality assurance, and the Senior Lead to keep project milestones on track.

Qualifications & Experience

• Bachelor’s degree in Mechanical, Manufacturing, or Biomedical Engineering.
• 6–12 years professional experience in manufacturing engineering within the Medical Device or highly regulated sectors (e.g., Aerospace or Automotive).
• Proven track record of leading large‑scale projects, implementing advanced manufacturing technologies, and driving continuous improvement; experience in medical device consumables is an added advantage.

Benefits

As per Quest company policy.