Director, Hardware & Systems Engineering at Danaher Corporation

Bengaluru, Karnataka, India

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, DiagnosticsIndustries

Requirements

Bachelor’s degree in an engineering discipline (Mechanical, Electrical, Systems, Biomedical); advanced degrees (Master’s or Ph.D.) strongly preferred
Minimum of 20 years in complex hardware product development, including at least 15 years in senior leadership roles managing multiple engineering disciplines
Extensive, mandatory experience within the diagnostic, medical device, or in-vitro diagnostic (IVD) industry
Proven track record overseeing the complete product lifecycle for integrated systems involving hardware, software

Responsibilities

Lead, develop, and inspire a large, multi-disciplinary organization comprising Systems, Mechanical, Electrical, Firmware, and Prototyping engineering; define the organizational structure, hire and retain top talent, and cultivate a culture of innovation, quality, and execution
In partnership with executive leadership, define and drive the multi-year technology and product roadmap for all hardware and systems; champion advanced technology research and feasibility studies to build a pipeline for next-generation platforms
Champion a robust, systems-driven development process; oversee the definition of system requirements, architectural design, interface control, risk management (FMEA), and the overall integration, verification, and validation (V&V) strategy
Direct the entire hardware and firmware development lifecycle across all product lines; ensure programs are properly resourced and executed on schedule and within budget, meeting rigorous performance and quality standards
Be ultimately accountable for ensuring that all hardware and firmware development processes and documentation adhere to global regulatory standards, including ISO 13485 Quality Management System, FDA QSR (21 CFR 820), IEC 60601-1 (Safety & EMC), and IEC 62304 (Software Lifecycle)
Serve as a key strategic partner to the leaders of Software, Assay Development, Quality, Regulatory, and Operations; drive seamless collaboration to ensure the successful development and commercialization of fully integrated diagnostic systems
Oversee the prototyping labs and technical services; drive continuous improvement initiatives to enhance design processes, tools, and team efficiency
Provide strategic and operational leadership for the entire physical product engineering organization as the single point of ownership for the architecture, design, development, and verification of all hardware and embedded software for complex diagnostic instruments; set the technical vision, drive innovation, and ensure flawless execution from concept to market launch and beyond

Skills

Key technologies and capabilities for this role

Hardware EngineeringSystems EngineeringMechanical EngineeringElectrical EngineeringFirmwarePrototypingEmbedded SoftwareDiagnostic InstrumentsMedical DevicesProduct ArchitectureDesign VerificationTeam LeadershipTechnical Roadmap

Questions & Answers

Common questions about this position

Is this position remote or on-site?

This position will be based on-site at the Bengaluru IDC location in India.

What teams will I be responsible for leading?

You will direct the Systems, Mechanical, Electrical, Firmware, and Prototyping teams as the single point of ownership for hardware and embedded software.

What key skills and experience are required for this role?

The role requires proven leadership in building and scaling high-performing, multi-disciplinary teams in a regulated diagnostic/medical device environment, expertise in systems engineering including requirements definition, architecture, risk management (FMEA), integration, verification, and validation, and deep knowledge of regulatory standards like ISO 13485, FDA QSR, IEC 60601-1, and IEC 62304.

What is the company culture like for this team?

The culture emphasizes innovation, quality, and execution, with a focus on developing and inspiring multi-disciplinary teams to create life-saving diagnostic technologies.

What makes a strong candidate for this Director role?

A strong candidate is a visionary executive with a proven track record of building and scaling teams in regulated medical device environments, experience driving technology roadmaps, ensuring regulatory compliance, and delivering end-to-end hardware and systems execution from concept to market.

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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