Manufacturing Engineering Lead

Job Requirements

At Quest Global, it’s not just what we do but how and why we do it that makes us different. With over 25 years as an engineering services provider, we believe in the power of doing things differently to make the impossible possible. Our people are driven by the desire to make the world a better place—to make a positive difference that contributes to a brighter future. We bring together technologies and industries, alongside the contributions of diverse individuals who are empowered by an intentional workplace culture, to solve problems better and faster.

Job Description: Manufacturing Engineering Lead

Location: Chennai

Experience: 6 – 12 Years

Industry: Medical Devices

Role Overview

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

Key Responsibilities

Process Development & Technical Execution

• Execute process improvements activities under the guidance of the Senior Lead to enhance production efficiency.
• Collaborate with design teams to apply Design for Manufacturing (DFM) and Assembly (DFA) principles, ensuring new products are optimized for high-volume production.
• Create and maintain detailed manufacturing work instructions, SOPs, and technical specifications with a focus on precision and clarity.
• Perform Root Cause Analysis (RCA) on production line failures or yield issues using tools like 8D or Fishbone, implementing corrective actions to prevent recurrence.

Validation & Quality Compliance

• 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 standards; 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 ensure project milestones stay on track.

Qualifications & Experience

• Education: Bachelor’s degree in mechanical, Manufacturing, or Biomedical Engineering.
• Experience: 6–12 years of professional experience in manufacturing engineering, specifically within the Medical Device or highly regulated sectors (e.g., Aerospace or Automotive).
• Technical Skills: 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.

Work Experience

Qualifications & Experience

• Education: Bachelor’s degree in mechanical, Manufacturing, or Biomedical Engineering.
• Experience: 6–12 years of professional experience in manufacturing engineering, specifically within the Medical Device or highly regulated sectors (e.g., Aerospace or Automotive).
• Technical Skills: 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