Senior Engineer, Quality Assurance

Senior Engineer, Quality Assurance

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.

The Senior Engineer, Quality Assurance 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

The essential requirements of the job include:

• BS/BA in Engineering or a technical field
• Minimum of five years of experience in the 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)

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Ability to travel up to 10% of the time (domestic)
• Ability to lift, move, or carry equipment up to 20 lbs

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

• 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

The salary range for this role is $130,000 - $142,000. 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 range may be modified in the future.

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.

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.