Senior Software Quality Engineer

Danaher•Vista, CA

12d•$130,000 - $142,000•Onsite

About The Position

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Biosystems, 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 Leica Biosystems, we’re not just shaping the future of cancer diagnostics — we’re transforming lives. Our mission of “Advancing Cancer Diagnostics, Improving Lives” is the driving force behind everything we do. As a global leader with the most comprehensive portfolio spanning from biopsy to diagnosis, we empower clinicians with innovative, reliable solutions so they can give patients timely, accurate answers when they need them most. When you join Leica Biosystems, you’re not just taking a job; you’re becoming part of a passionate team that knows every moment matters when it comes to cancer. You’ll help develop diagnostic solutions that turn anxiety into answers, and aid the acceleration of next-generation, life-changing therapies. Surrounded by a diverse and collaborative global community, you’ll be inspired each day to stretch, grow, and make an impact. Learn about the Danaher Business System which makes everything possible. The Senior Software Quality Engineer for Leica Biosystems is responsible for providing Quality Engineering support for end-to-end design, software, and hardware development projects. This position reports to the Manager, Quality Assurance and is part of the Quality Assurance team located in Vista, California and will be an on-site role. In this role, you will have the opportunity to: Work independently and with cross-functional project team members to develop process and design deliverables including quality plans, design, software development, manufacturing and auditing documentation, test methods, and Device History Records and assist with the development of project verification and validation activities Own the development and maintenance of the product risk management process, hazard analysis, and assist with cybersecurity, FMEAs for multiple projects in accordance with ISO 14971 and ISO 62304 Assist in troubleshooting and root cause analysis for issues faced during execution of process verifications, validations, and Design Transfer to manufacturing in accordance with established procedures and transfer schedules Work closely with Research and Development and Regulatory Affairs on deliverables for global regulatory submissions, including FDA pre-submissions, 510k, and IVDR CE certifications Participate in the performance and documentation of internal and external audits and respond to audit findings by proposing and implementing necessary corrective actions

Requirements

BS/BA in Engineering or a technical field
Minimum of five years of experience in quality field in a medical device, IVD, or similarly regulated industry with emphasis on software development
Experience with design controls within a regulated industry including strong working knowledge of ISO 13485, ISO 14971 and 21 CFR 820
Demonstrated experience in problem solving, root cause analysis, and implementing corrective and preventive actions to prevent recurrence
Ability to effectively communicate (verbal and written) information in English (Ability to communicate in Spanish is a plus)
Ability to travel up to 10% of the time (domestic)
Ability to lift, move, or carry equipment up to 20 lbs

Nice To Haves

Effective presentation/communication skills and project/resource management skills
Ability to work independently and in a team environment, including with management and technical staff
Experience with Agile software development, Cybersecurity, and AI knowledge

Responsibilities

Work independently and with cross-functional project team members to develop process and design deliverables including quality plans, design, software development, manufacturing and auditing documentation, test methods, and Device History Records and assist with the development of project verification and validation activities
Own the development and maintenance of the product risk management process, hazard analysis, and assist with cybersecurity, FMEAs for multiple projects in accordance with ISO 14971 and ISO 62304
Assist in troubleshooting and root cause analysis for issues faced during execution of process verifications, validations, and Design Transfer to manufacturing in accordance with established procedures and transfer schedules
Work closely with Research and Development and Regulatory Affairs on deliverables for global regulatory submissions, including FDA pre-submissions, 510k, and IVDR CE certifications
Participate in the performance and documentation of internal and external audits and respond to audit findings by proposing and implementing necessary corrective actions