Senior Quality Engineer

Qualifications
Lead quality engineering efforts for PCR-based assay development, including analytical method validation, reagent qualification, and system-level performance verification
Drive risk assessment activities including safety, design and process FMEA, with a focus on assay sensitivity, reagent compatibility, specificity, and robustness
BS degree in chemistry, molecular biology, biomedical engineering, or related field with 5+ years of quality engineering experience, master’s degree with 3+ years experience, OR Doctoral degree with 1+ year(s) experience
Proven experience in working with the assay development, including method validation, troubleshooting, performance characterization and continuous process improvement for biological assays and processes
Experienced in NPI Quality for complex systems, including design verification and validation, part qualification and test method validation
Experience in the application of process control plans, statistical process control, and quality system regulations (e.g., 21 CFR 820, ISO 13485)
Demonstrated ability to lead cross-functional teams and guide product development from concept to commercialization
Experience in biomedical or medical device manufacturing
Certified Quality Engineer and/or Lead Auditor certification
Benefits
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
The annual salary range for this role is $111,100 – 135,500
This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting
This job is also eligible for bonus/incentive pay
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable
The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law
Responsibilities
The Senior Quality Engineer is responsible for driving manufacturing and product lifecycle quality by implementing a risk-based approach to ensure compliance with corporate policies, 21 CFR 820, ISO 13485, and other regulatory standards, while championing continuous improvement
You will play a pivotal role in New Product Introduction (NPI) and Change Control processes, ensuring accurate and complete quality deliverables during design transfer to manufacturing
This includes reviewing change orders and deviations to confirm clear, well-documented rationales and comprehensive impact assessments for significant changes
By developing robust qualification strategies, you will proactively mitigate risks associated with design and process modifications, enhancing product reliability and supporting innovative product development
This position reports to the Sr Manager of Quality Engineering and is part of the Quality Engineering team located in Sunnyvale, CA, and will be an on-site role
Serve as the primary Quality Engineering representative on cross-functional teams for new product introduction and manufacturing sustainment, providing strategic input on design control, risk management, and quality compliance
Create project-specific documents, such as validation master plans, risk management plans, and qualification protocols, to meet compliance requirements
Address nonconformities and deviations through risk assessment, root cause identification, failure mode analysis, and proposing disposition
Job 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 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 Senior Quality Engineer is responsible for driving manufacturing and product lifecycle quality by implementing a risk-based approach to ensure compliance with corporate policies, 21 CFR 820, ISO 13485, and other regulatory standards, while championing continuous improvement. You will play a pivotal role in New Product Introduction (NPI) and Change Control processes, ensuring accurate and complete quality deliverables during design transfer to manufacturing. This includes reviewing change orders and deviations to confirm clear, well-documented rationales and comprehensive impact assessments for significant changes. By developing robust qualification strategies, you will proactively mitigate risks associated with design and process modifications, enhancing product reliability and supporting innovative product development.

This position reports to the Sr Manager of Quality Engineering and is part of the Quality Engineering team located in Sunnyvale, CA, and will be an on-site role.

In this role, you will have the opportunity to:
• Lead quality engineering efforts for PCR-based assay development, including analytical method validation, reagent qualification, and system-level performance verification.
• Serve as the primary Quality Engineering representative on cross-functional teams for new product introduction and manufacturing sustainment, providing strategic input on design control, risk management, and quality compliance.
• Drive risk assessment activities including safety, design and process FMEA, with a focus on assay sensitivity, reagent compatibility, specificity, and robustness.
• Create project-specific documents, such as validation master plans, risk management plans, and qualification protocols, to meet compliance requirements.
• Address nonconformities and deviations through risk assessment, root cause identification, failure mode analysis, and proposing disposition.

The essential requirements of the job include:
• BS degree in chemistry, molecular biology, biomedical engineering, or related field with 5+ years of quality engineering experience, master’s degree with 3+ years experience, OR Doctoral degree with 1+ year(s) experience.
• Proven experience in working with the assay development, including method validation, troubleshooting, performance characterization and continuous process improvement for biological assays and processes.
• Experienced in NPI Quality for complex systems, including design verification and validation, part qualification and test method validation.
• Experience in the application of process control plans, statistical process control, and quality system regulations (e.g., 21 CFR 820, ISO 13485).
• Demonstrated ability to lead cross-functional teams and guide product development from concept to commercialization.

It would be a plus if you also possess previous experience in:
• Experience in biomedical or medical device manufacturing
• Certified Quality Engineer and/or Lead Auditor certification

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.

The annual salary range for this role is $111,100 – 135,500. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting.

This job is also eligible for bonus/incentive pay.

We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.

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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.

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We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or applyassistance@danaher.com.