Director, Hardware

At Cepheid our Bengaluru R&D Center is the global engine driving the future of diagnostics. We are an organization of innovators dedicated to creating sophisticated, life-saving technologies that provide faster, more reliable clinical insights. We are looking for a world-class executive to lead our integrated hardware and systems engineering organization and play a pivotal role in shaping the next generation of diagnostic platforms that will impact millions of lives.

We are seeking a visionary and highly accomplished Director of Hardware & Systems Engineering to provide strategic and operational leadership for the entire physical product engineering organization. This executive role is responsible for directing the Systems, Mechanical, Electrical, Firmware, and Prototyping teams. You will be the single point of ownership for the architecture, design, development, and verification of all hardware and embedded software for our complex diagnostic instruments. The ideal candidate is a seasoned leader with a proven track record of building and scaling high-performing, multi-disciplinary teams in a regulated diagnostic/ medical device environment. You will be responsible for setting the technical vision, driving innovation, and ensuring flawless execution from concept to market launch and beyond.

This position is part of the Research & Development department, located in Bengaluru, IDC, India, and will be based on-site.

In this role, you will have the opportunity to:

• Executive Leadership & Organizational Strategy: 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.
• Technology & Product Roadmap: 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.
• Systems Engineering Excellence: 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.
• End-to-End Execution: 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.
• Regulatory & Quality Supremacy: Be ultimately accountable for ensuring that all hardware and firmware development processes and documentation adhere to global regulatory standards, including our ISO 13485 Quality Management System, FDA QSR (21 CFR 820), IEC Safety & EMC), and IEC Software Lifecycle).
• Cross-Functional Partnership: 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.
• Operational Excellence: Oversee the prototyping labs and technical services. Drive continuous improvement initiatives to enhance design processes, tools, and team efficiency.

The essential requirements of the job include:

• 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, and firmware.
• Demonstrated ability to build, scale, and lead large engineering organizations (30+ professionals) across Systems, Mechanical, Electrical, and Firmware disciplines.
• Expert-level understanding of global diagnostic and medical device regulations and standards, including ISO 13485, FDA design controls, IEC , and IEC 62304.
• History of driving innovation, operational excellence, and compliance in highly regulated environments while delivering complex products to market.

It would be a plus if you also possess previous experience in:

• An MBA or advanced management training.
• Experience with complex systems involving robotics, microfluidics, optics, and advanced thermal control.
• Proven ability to think strategically, articulate a vision, and drive it to execution.
• Strong business acumen with experience managing multi-million-dollar budgets.
• Exceptional executive communication and influencing skills.

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

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