Director, Systems Engineering 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, BiotechnologyIndustries

Requirements

Minimum 15 years of experience in software-driven electro-mechanical product development, including at least 7 years in a senior systems engineering leadership role
Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, or a related discipline
Demonstrated leadership of full systems engineering lifecycle using the V-model, including requirements definition, system architecture, integration, verification, and validation
Proven track record of launching at least three regulated medical or diagnostic products to market under FDA and international regulatory frameworks
Hands-on management of cross-functional engineering teams responsible for system architecture, integration, verification and validation (V&V), and reliability engineering
Expert-level proficiency in model-based systems engineering (MBSE) frameworks, requirements management tools such as IBM DOORS or Jama Connect, and regulatory standards including ISO 13485, FDA QSR (21 CFR 820), ISO 14971

Responsibilities

Direct the systems engineering function across architecture, integration, verification, validation, and reliability, ensuring alignment with ISO 13485 and FDA QSR (21 CFR 820) standards
Oversee end-to-end requirements management, translating clinical workflows into technical specifications using tools such as IBM DOORS or Jama Connect
Lead system architecture development, including trade-off analysis and platform scalability decisions, with proficiency in model-based systems engineering (MBSE) frameworks
Manage integration of multidisciplinary subsystems—hardware, software, firmware, and biochemical assays—using structured integration plans and risk-based methodologies
Own the V&V strategy and execution, including authoring and approving test protocols and reports for regulatory submissions under FDA and CE marking requirements
Implement reliability engineering practices including FMEA, HALT/HASS, and predictive analytics to meet product lifetime targets and reduce field failure rates
Administer product risk management activities per ISO 14971, ensuring traceable mitigation strategies across the full product lifecycle using validated risk analysis tools
Lead System Architects, System Integration Engineers, Verification & Validation (V&V) Engineers, and Reliability Engineers to define, integrate, verify, and ensure the reliability of complex products

Skills

Systems Engineering

System Architecture

System Integration

Verification & Validation

Reliability Engineering

Molecular Diagnostics

Regulatory Standards

R&D Leadership

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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