Senior Software Quality Engineer
Cepheid

Job Info

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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 which makes everything possible.

The Senior Software Quality Engineer will support the quality system activities related to software development, with a focus on design control and risk management in accordance with FDA and ISO regulations. This position contributes to the completion of milestones associated with software projects and activities using existing procedures. Senior Software Quality Engineer requires minimal supervision and guidance in the performance of their duties and requires in-depth knowledge and experience in software quality and design controls.

This position is part of the Product Software Quality team and will be located in Sunnyvale, CA. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.

In this role, you will have the opportunity to:

• Participate in Software core teams as a technical lead to provide guidance on design control deliverables and Cybersecurity requirements.

• Define design validation strategies and lead validation execution activities.

• Collaborate with project core team to engage internal and external users during design validation activities.

• Collaborate with the project core team to identify safety and security risks through a formal risk assessment per SOPs.

• Work closely with Regulatory Affairs to develop a package for software 510(k) and PMA submissions.

The essential requirements of the job include:

• BA/BS degree in any Science or Engineering field with 5+ years of Software Quality Engineer experience in regulated industry.

• Proficiency and working knowledge in Design controls, IEC-62304, Cybersecurity, ISO-14971 and ISO-13485 regulations.

• Proven history of working with complex projects in multiple release cycles.

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.

• Experience working with software tools such as Agile, Complaint tracking, requirements management, defect tracking systems.

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 mydanaherbenefits.com #L1-WT1

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 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.

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 applyassistance@danaher.com to request accommodation.

If you've ever wondered what's within you, there's no better time to find out.

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