Sr Staff Engineer, Systems Verification

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we're working at the pace of change on diagnostic tools that address the world's biggest health challenges, driven by knowing that behind every test there is a patient waiting.

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The Senior Staff Engineer, Systems Verification is responsible for verification tasks related to hardware, consumables, software, and assay interoperability, with the goal of evaluating overall system performance requirements for Cepheid's diagnostic platforms. In this hands-on role, you will work with R&D, Failure Investigation, Mechanical, Optical, and Electrical Engineering, Software, NPI, Consumables, and other interdisciplinary groups to design, refine, and test various instrument components/systems for in vitro diagnostic projects. The Sr. Staff Systems Verification Engineer is responsible for the planning, execution, analysis, and reporting of laboratory experiments in support of new product development projects. The ideal candidate will have an engineering background with additional experience working in biological settings in a regulated, medical device environment with knowledge in verification of integrated systems.

This position is part of the Systems Engineering team and will be in Bengaluru, IDC, India. At Cepheid we are committed to providing high reliable products and service that consistently meet or exceed customers' expectations. The focus on reliability begins at the earliest stage of product design and carries through to the end user.

In this role, you will have the opportunity to:

• Lead verification testing for instrumentation platforms, including test planning, execution, and coordination with extended verification teams to meet project schedules
• Design and implement complex test methods and fixtures to evaluate hardware and system performance against Design Input Requirements in compliance with Quality and Regulatory requirements
• Work independently in a cross-disciplinary environment to plan and execute experiments using specialized test equipment, perform experimental data analysis, maintain organized documentation of activities, and provide regular updates on progress, problems, and solutions
• Generate technical reports and data packages for senior and executive management, including statistical analysis outputs and documented verification results
• Maintain complete documentation in compliance with Quality Management Systems and collaborate with Hardware Engineering, Innovation, Biotechnology R&D, Consumable R&D, Technical Support, Firmware, Software, Services and NPI teams to deliver oncology and infectious disease diagnostic platforms

The essential requirements of the job include:

• Bachelor's degree in Engineering, Molecular Biology, Life Sciences, or related technical discipline with 8+ years of experience OR Master's degree in Electrical, Mechanical, or Biomedical Engineering with 6+ years OR Doctoral degree with 3+ years related work experience in systems engineering, systems integration, or R&D
• Proficiency in statistical data analysis using Excel and advanced tools such as Origin, Matlab, R, Python, Mathematica, or Minitab for quantitative data evaluation and presentation
• Direct experience in systems verification of complex instrumentation systems with multiple interoperable sub-systems, including optical, mechanical, thermal, and firmware components
• Demonstrated execution of verification plans, protocols, test methods, and technical reports in regulated environments (FDA, ISO, IEC, CLIA, CAP)
• Hands-on operation of sophisticated instrumentation and computer-controlled hardware, including environmental chambers and laboratory equipment for reagent handling and pipetting

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

• General scientific lab experience required with biomedical engineering, bioengineering, and physics background and/or with GMP and GLP experience is a plus.
• Experience in a Quality Environment and experience with Polymerase Chain Reaction (PCR) or other biological applications of fluorescence.
• Design and Development testing, and Verification experience.

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.

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