Lead Mechanical Engineer II

Overview

Sustain and improve complex manufacturing systems for high-volume production, focusing on assembly efficiency, components, tooling and equipment, and process robustness at Cepheid, a Danaher operating company.

What you'll do

• 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

What you'll need

• 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

Nice to have

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

Details

• Location: Bangalore, India
• Work mode: On-site
• Reports to the Sr. Manager, NPI Manufacturing Engineering, IDC
• Part of the Global Instrument Operations and Global Supply Chain Organization
• Travel: 10-25%