Job Summary

The Manufacturing Engineering, Mechanical position is responsible for sustaining and improving complex manufacturing systems for high-volume production. This role focuses on enhancing assembly efficiency, developing and refining components, tooling and equipment, and ensuring robust processes through risk assessment and validation activities. The engineer will troubleshoot and resolve technical issues on the production floor and suppliers, implement improvements to boost throughput and product reliability, and partner with cross-functional teams to make designs easier to build and scale.

This position reports to the Sr. Manager, NPI Manufacturing Engineering, IDC and is part of the Global Instrument Operations and Global Supply Chain Organization. This position is located in Bangalore, India and will be an on-site role.

Responsibilities

- Develop, refine, and maintain high volume manufacturing documentation including BOMs, workflows, assembly plans, and work instructions to optimize process efficiency and compliance
- Design, qualify, and implement manufacturing tools, fixtures, and equipment and execute reliability, repeatability, and cost effectiveness improvements across production lines
- Perform PFMEA, validation activities (IQ/OQ/PQ), and critical testing to mitigate production risks and ensure adherence to medical device quality systems and regulatory standards
- Execute root cause analysis, failure analysis, corrective actions,



and change order implementation for product and process issues and generate required engineering documentation
- Lead manufacturing scalability and cost reduction initiatives by qualifying new manufacturing partners, resolving supplier technical and quality issues, and driving DFM improvements to part drawings, tolerances, and specifications

Essential requirements

- Bachelor's degree in Mechanical Engineering, Mechatronics, or equivalent discipline with 5+ years of mechanical manufacturing development experience
- Demonstrated experience in process, equipment, and product validation and verification activities
- Proven industry experience supporting mechanical manufacturing development within regulated or high volume production environments
- Proficiency in executing validation protocols and qualification activities for mechanical systems, tooling, and equipment
- Ability to meet physical and operational requirements, including 10-25% travel, valid driver's license with acceptable driving record, and capability to lift up to 25 lbs

Preferred qualifications

- Experience with NPI process, and Design Control process
- Experience with CAD (preferred Solidworks)
- Experience working in a product development setting and/or within manufacturing operations under cGMP, ISO and FDA regulations

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Lead Mechanical Engineer I (Karnataka)
🏢 DHR Holding India
📍 Karnataka