Firmware Architect

Zydus Medtech; Bengaluru; On-site; INR 4,000,000 - 6,500,000; Full time

Job summary

Zydus Medtech is seeking a Principal Firmware Architect to lead the Medical device firmware R&D effort in Bengaluru. The role blends people management with technical authority, defining the firmware platform strategy across the portfolio and ensuring regulatory compliance.

You will build a core engineering team, own platform roadmaps, and act as the principal authority for architectural quality and SDLC/governance across programs.

Qualifications

• Experience delivering regulated medical device firmware through FDA 510(k), CE, or equivalent.
• Deep knowledge of IEC 62304, ISO 14971 and ISO 13485 and applying them to design history files.
• Proven track record leading teams through complete product development cycles from concept to launch.

Responsibilities

• Build, lead and grow a core firmware team across two pods: Safety & Platform and Systems & Integration.
• Own hiring, onboarding, performance management, career development and retention.
• Define firmware platform roadmap across multiple device generations with safety and regulatory focus.
• Serve as principal firmware technical authority for architectural quality and design decisions.
• Own IEC 62304 SDLC and ISO 14971 risk management sign-off for all firmware deliverables.
• Resolve critical field issues, CAPAs, and FSCAs as firmware domain authority.
• Establish firmware quality metrics and drive continuous improvement programs.
• Partner with Systems Architecture, Quality, Regulatory Affairs, and Clinical teams.
• Represent firmware in program reviews and cross-site technical forums.
• Exhibit hands-on embedded development and evaluate new tools and practices.

Skills

Leadership

Stakeholder management

Embedded firmware development

Regulatory compliance

People management

Architecture & design

Education

BE/B.Tech or M.Tech in Electronics/Embedded Systems/Biomedical Engineering/CS

Job description

The Principal Firmware Architect is the foundational leadership role for the Medical device firmware R&D team.

This is a dual-track position combining people management with principal-level technical authority.

You will build and lead a core engineering team, define the firmware platform strategy across the device portfolio, and serve as the regulatory and technical authority for all firmware deliverables.

This role reports to senior R&D leadership and has full accountability for team outcomes, quality, and regulatory compliance.

Key Responsibilities :

• Build, lead, and grow a team of core firmware engineers across two pods Safety & Platform and Systems & Integration.
• Own hiring, onboarding, performance management, career development, and retention for the entire firmware team.
• Define firmware platform roadmap across multiple medical device product generations, balancing innovation, safety, and regulatory compliance.
• Serve as the principal firmware technical authority accountable for architectural quality, platform coherence, and design decisions across all programs.
• Own IEC 62304 SDLC process framework and ISO 14971 risk management sign-off across all firmware deliverables.
• Drive resolution of critical field issues, CAPAs, and field safety corrective actions (FSCAs) as the firmware domain authority.
• Establish firmware quality metrics (defect density, static analysis compliance, code coverage) and run continuous improvement programs.
• Partner with Systems Architecture, Quality, Regulatory Affairs, and Clinical teams to ensure firmware supports device-level requirements.
• Represent the firmware team in global program reviews, executive stakeholder reporting, and cross-site technical forums.
• Exhibits hands-on embedded software development, Evaluate and introduce new tools, methodologies, and development practices to improve team productivity and firmware quality.

Required Qualifications :

• B.E./B.Tech or M.Tech in Electronics, Embedded Systems, Biomedical Engineering, or Computer Science.
• 12+ years of embedded firmware experience, with 4-6 years in a formal people management or principal technical leadership role.
• Proven track record delivering regulated medical device firmware through FDA 510(k), CE, or equivalent regulatory pathways.
• Deep knowledge of IEC 62304, ISO 14971, and ISO 13485; practical experience applying them to design history files.

Experience leading teams through complete product development cycles from concept through commercial launch and post-market sustaining.

• Strong stakeholder management and executive communication skills ability to align engineering, quality, regulatory, and business leadership.
• Demonstrated success growing engineers into senior and architect-level contributors.

Preferred Qualifications

• Direct medical devices (such as cardiac, respiratory, or drug delivery) firmware experience.
• Experience managing through FDA inspection, ISO 13485 audit, or CE notified body review.
• Exposure to Design for Six Sigma (DFSS), structured problem solving (8D, 5-Why), and SAFe at program level.
• Prior experience with R&D center establishment or collaborative integration at a global MedTech company.