Danaher Corporation Staff Systems Quality Engineer (Hybrid) in Sunnyvale, California
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.
Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible.
The Staff Systems Quality Engineer is responsible to support design validation activities related to assay, instrument, integrated circuits, and software development with focus on design controls and Human Factors Engineering in accordance with FDA and ISO regulations.
This position is part of the Product Life cycle Quality department and will be a Hybrid role located in Sunnyvale. At Product Lifecycle Quality, our vision is to deliver Quality products to our customers.
In this role, you will have the opportunity to:
Participate in product development core teams as a quality representative to provide guidance on design control deliverables at the system level. This includes defining design validation strategies, overseeing test architecture from the system perspective, and developing complete traceability from user needs to risk mitigations to validation protocols.
Conduct safety risk analysis, participate in design and security risk analysis.
Perform impact analyses for the post market product design changes.
Drive continuous improvements with changes in business needs, new and updated changes in guidelines from FDA and other regulatory agencies.
Develop and maintain design control KPIs and participate in internal and external audits as an SME.
The essential requirements of the job include:
Bachelor's degree with 8+ years of related work experience in regulated industry OR Masters degree with 6+ years of related work experience in regulated industry
Proficiency and working knowledge in Design controls, ISO-14971 and ISO-13485 regulations
Experience working with complex projects in multiple release cycles
Experience in leading design validation activities, HFE activities and risk management activities
It would be a plus if you also possess previous experience in:
Quality Engineering certification from American society for quality (ASQ) or other qualifying organizations such as CRE, CQA
Hands on experience with advanced statistical analysis
Experience working with software tools such as Agile, Complaint tracking, requirements management, defect tracking systems
At Cepheid we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cepheid can provide.
Cepheid, a Danaher 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 danaherbenefitsinfo.com.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.
Operating Company: Cepheid