Senior Software Quality Engineer at Danaher Corporation

Vista, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Diagnostics, Biotechnology, Medical Devices, Cancer DiagnosticsIndustries

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

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

Skills

Software Quality Engineering

Quality Assurance

Design Control

Process Development

Cross-functional Collaboration

Danaher Business System

Danaher Corporation

Water quality, diagnostics, and identification solutions

About Danaher Corporation

Danaher Corporation operates in key markets such as water quality, product identification, and diagnostics. The company provides precision instruments and advanced purification technologies for analyzing and managing water, ensuring its safety in various environments. In product identification, Danaher specializes in laser marking, coding, and packaging solutions that help maintain product freshness and accurate labeling throughout the supply chain. In the diagnostics sector, Danaher offers tools and software that enhance diagnostic confidence, enabling healthcare providers to deliver effective care. What sets Danaher apart from competitors is its unique Danaher Business System, which focuses on continuous improvement and empowers employees to drive change. The company's goal is to consistently deliver high-performance products and solutions while maintaining leadership in its markets.

Washington, District of ColumbiaHeadquarters

1969Year Founded

IPOCompany Stage

Industrial & Manufacturing, Healthcare, Consumer GoodsIndustries

10,001+Employees

Risks

Increased competition from Roche and Abbott in AI-driven diagnostics.

Potential regulatory challenges in the EU for water quality sector.

Supply chain vulnerabilities affecting precision instruments sourcing.

Differentiation

Danaher's Danaher Business System drives continuous improvement and superior financial performance.

The acquisition of Cytiva enhances Danaher's capabilities in the biopharmaceutical sector.

Danaher's advanced purification technologies meet increasing demands for sustainable water management.

Upsides

Danaher's investment in AI-driven healthcare solutions boosts its diagnostics capabilities.

Cytiva acquisition expands Danaher's market share in the biopharmaceutical sector.

Point-of-care testing demand drives growth for Danaher's diagnostic tools and software.

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