Description
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Cepheid, one of Danaher’s (https://danaher.com/our-businesses) 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 (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Manager, Pilot Lab Operations is responsible for new product build efforts in support of New Product Development and Design and Transfer to production at our contract manufacturer. The Manager, Manufacturing Pilot Line position requires frequent interaction with cross-functional partners to coordinate development and prototype builds used for informing downstream engineering and production efforts to enable efficient product launch timeframes. As the Manager, Pilot Lab Operations , IDC, you will support the development builds and special projects to maintain timelines, balance workloads, and deliver quality builds on time.
This position is part of the Instruments Global Supply Chain Operations team and will be located in Bangalore, India in an onsite IDC role. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.
In this role, you will have the opportunity to:
+ Define scope, schedule pilot builds, allocate equipment and lab space resources, and track progress using ERP systems (SAP or Oracle)
+ Manage Pilot Line and NPI lab operations to support prototype and pilot builds, ensuring throughput metrics are met
+ Perform instrument decontamination and execute failure analysis investigations using industry-standard reliability and compliance protocols (e.g., ISO, FDA)
+ Develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for new product builds and concepts
+ Create and update design control documentation, product configurations including Device History Records (DHRs) and Bills of Materials (BOMs), in compliance with Quality System Regulations
+ Capture and analyze build findings to support process and product improvement projects in collaboration with R&D and Quality engineering teams
+ Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) across pilot builds, documentation, and lab operations
The essential requirements of the job include:
+ Bachelor’s degree with 9+ years of experience OR Master’s degree with 7+ years of related work experience. Degree in relevant fields such as Physics, Applied Physics, Biology, Bioengineering, Biomedical Engineering, Mechanical Engineering, Fluidics
+ Must have experience with complex product development, including developing and integrating complex instrumentation systems
+ Utilize your understanding of production, prototyping, and fabrication process and the time, cost, and quality tradeoffs to support the function and growth of the team
+ Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and tasks
+ Available for periodic travel (10–25%) to support manufacturing operations, process implementation, and cross-functional collaboration across multiple sites.
+ Must have a valid driver’s license with an acceptable driving record
+ Ability to lift, move or carry equipment up to 25 lbs, any other physical requirements
It would be a plus if you also possess previous experience in:
+ Experience and knowledge of ISO/FDA-regulated industry.
+ Medical Products industry experience.
Cepheid, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .
At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.
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 .
Operating Company: Cepheid
