Lead Mechanical Engineer II

Cepheid; Bengaluru; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Cepheid, a Danaher company, seeks a Manufacturing Engineering, Mechanical specialist in Bangalore to sustain and improve high-volume assembly, tooling, and processes for medical device production.

You will perform PFMEA, IQ/OQ/PQ, and drive DFM improvements while collaborating with cross-functional teams to boost throughput and product reliability. Requires 5+ years in mechanical manufacturing within regulated environments.

Qualifications

• Bachelor’s degree in Mechanical Engineering or Mechatronics with 5+ years of mechanical manufacturing development experience.
• Proven experience validating and verifying processes, equipment, and products.
• Experience in regulated or high-volume production environments with mechanical systems.

Responsibilities

• Develop, refine, and maintain high-volume manufacturing documentation and workflows.
• Design, qualify, and implement tooling and equipment with cost-effective improvements.
• Perform PFMEA, IQ/OQ/PQ, and critical testing to mitigate risks and ensure quality systems compliance.
• Lead root cause analysis and change actions for product and process issues.
• Drive scalability and cost-reduction by qualifying new partners and improving part drawings.

Skills

Mechatronics

Mechanical design

Process validation

NPI processes

Education

Bachelor's degree in Mechanical Engineering or equivalent

Tools

CAD (SolidWorks)

Job description

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you’ll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world’s most complex health challenges. Together, we bring MORE change to the world. Learn about the Danaher Business System which makes everything possible.

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.

In this role, you will have the opportunity to:

• 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

The essential requirements of the job include:

• 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

It would be a plus if you also possess previous experience in:

• 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

Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow.

The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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