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Danaher Corporation Senior Design Quality Engineer in Vista, California

Leica Biosystems associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our team as a Senior Design Quality Assurance Engineer and be inspired to grow every day. Learn more about Leica at www.leicabiosystems.com.

The primary role of the Quality Engineer is to provide Quality Engineering support for software and hardware development projects. This includes providing specific project deliverables, as well as, providing review and guidance for Traceability Matrix, Design History File (DHF), risk management and Design verification and validation activities related to the product development projects. Highly focused on design and development of software and hardware products and quality processes.

Responsibilities we will trust you with:

  • Participate in cross-functional teams at various phases of the development cycle as the Quality Engineering representative. Work independently and with project team members to develop design control deliverables including quality plans, design controls deliverables, test method qualifications, and Design History Files.

  • Support development teams in State of the Art (SOTA) methods and processes for the design verification and validation of software and hardware products.

  • Work closely with Regulatory Affairs on deliverables for global regulatory submissions, including FDA pre-submissions, 510k and IVDR CE certifications.

  • Participate in the development and maintenance of product risk management documents, hazard analysis and FMEAs for multiple projects in accordance with ISO 14971.

  • Work independently and with project team members to develop and improve product and processes to reduce variability and increase robustness throughout the development cycle for multiple projects.

  • Supporting internal and external Audits and respond to Design Audit findings by proposing and implementing necessary corrective actions.

  • Identify Product and Design development constraints. Work with management and technical staff in performing root cause analysis and implementing corrective and preventive actions to product and Design development challenges.

  • Prepare regular performance reports for Quality Management Systems and project development. Maintain associated databases and design reports to reflect management input and changing organizational needs.

  • Meet company and departmental goals in the continuous improvement of all products, services and processes.

  • Audit Design Transfer deliverables and Trace Matrix in accordance with established procedures and Transfer schedules.

  • Assist in troubleshooting and root cause analysis for issues faced during execution of Design verifications, Design validations including Clinical trials.

  • Identify and support implementation of Design process improvements.

Your areas of knowledge and expertise that matter most for this role:

  • BS/BA in Engineering or a technical field

  • 8+ years experience in quality field in a medical device, IVD or similarly regulated industry

  • Experience with software and hardware development within a regulated industry including strong working knowledge of ISO 13485, ISO 14971, IEC 62304and 21 CFR 820

  • Effective presentation/communication skills, project/resource management skills helpful

  • Experience with AI/ML, Digital Health, Cybersecurity and Interoperability is plus

  • Ability to communicate in Spanish is a plus

% of Travel: <15%

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 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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