Lead Manufacturing Engineer
Full Job Posting
In this role, you will have the opportunity to:
Execution of transfer, localization, and integration projects. Coordinate with Product Management, Operations, RA/QA, Supply Chain, R&D, and external partners to achieve project success.
Define manufacturing equipment requirements and collaborate with internal teams and external machine builders to deliver solutions that support business growth and scalability.
Resolve issues related to fixtures, tooling, parts, and manufacturing systems to minimize impact on productivity, On-Time Delivery (OTD), and takt time.
Design, develop, and optimize robust manufacturing processes for existing products, and product enhancements, along with maintaining the process risk assessments and documentation, including pFMEA.
Lead process validation, equipment qualification, and scale-up from pilot to full production.
The essential requirements of the job include:
Bachelor’s degree in Manufacturing, Industrial, Mechanical, Electrical Engineering, or a related technical field with 7+ years in manufacturing engineering within a GMP environment. Knowledge of global medical device regulatory requirements and working in regulated and non-regulated product environments. Knowledge of relevant quality systems (e.g., ISO 13485, etc.).
Hands-on experience with global transfers, localization, integration, or complex launch programs, including process development & improvement, validation, and equipment qualification. Ability to run multiple projects simultaneously. Proven success driving Lean Manufacturing, Six Sigma and other initiatives.
Strong experience in manufacturing processes such as assembly, machining, fabrication, industrial automation, and inspection.
Excellent team-building, coaching, and analytical skills with a data-driven approach to decision-making. Experienced practitioner in TPM / PPM culture and OEE improvement.
Strong verbal and written communication abilities, capable of conveying complex technical concepts to varied audiences.
Language
Fluency in English both written and verbal.
Travel (required estimated % of time)
Travel ~10% (Based on the business needs).
It would be a plus if you also possess previous experience in:
Experience with CAD software and statistical analysis tools (e.g., Minitab, JMP).
Proficiency in project management.
Knowledge of AI/ML integration with automation.
Join our winning team today. 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.
Qualifications
- Bachelor’s degree in Manufacturing, Industrial, Mechanical, Electrical Engineering, or a related technical field with 7+ years in manufacturing engineering within a GMP environment. Knowledge of global medical device regulatory requirements and working in regulated and non-regulated product environments. Knowledge of relevant quality systems (e.g., ISO 13485, etc.).
- Hands-on experience with global transfers, localization, integration, or complex launch programs, including process development & improvement, validation, and equipment qualification. Ability to run multiple projects simultaneously. Proven success driving Lean Manufacturing, Six Sigma and other initiatives.
- Experience with CAD software and statistical analysis tools (e.g., Minitab, JMP).
About Cepheid
As a leading global life sciences and diagnostics innovator, we are committed to accelerating the power of science and technology to improve human health.
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