Staff Engineer, Product Transfer at Danaher Corporation

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Life Sciences, Diagnostics, Biotechnology, Medical DevicesIndustries

Requirements

Minimum 5 years of experience in software development, release engineering, or product transfer within a regulated medical device environment, including a bachelor’s or master’s degree in software engineering, computer science, electrical engineering, or related field
Proficiency in medical device software lifecycle standards (IEC 62304), quality systems (ISO 13485), and familiarity with FDA 21 CFR Part 820
Hands-on experience with system imaging tools such as Macrium, Clonezilla, MDT, or Acronis, and deployment on cloud platforms including AWS, Azure, or private cloud
Practical experience with CI/CD pipelines, Git-based version control, and build automation tools
Applied knowledge of software validation, risk management per ISO 14971, and cybersecurity standards including FDA cybersecurity guidance

Responsibilities

Execute software design transfer from R&D to manufacturing for PCR diagnostic instruments and embedded systems, ensuring compliance with FDA and ISO standards
Develop, validate, and deploy gold images and installation packages for Windows-based medical devices, servers, and embedded platforms used in production and field environments
Define and document installation procedures and deployment protocols, including image creation, validation, and configuration of Microsoft OS, security patches, and approved third-party components
Coordinate cloud-based deployment of medical software applications with validated cybersecurity controls, uptime monitoring, and data integrity safeguards
Generate and maintain traceable design transfer documentation including build records, IQ/OQ/PQ validation summaries, and manufacturing instructions for regulated software releases

Skills

Software Deployment

System Images

Software Patching

Regulatory Compliance

FDA

ISO 13485

IEC 62304

Cybersecurity

Cloud Production

Manufacturing Software

Vendor Management

R&D Transfer

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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