Embedded Firmware Architect

Zydus MedTech; Bengaluru; On-site; INR 2,800,000 - 5,200,000; Full time

Job summary

Zydus MedTech in Bengaluru is seeking an experienced Firmware Architect to lead the R&D team in a dual-role capacity, combining people leadership with principal-level technical expertise. The role oversees building firmware engineering teams, defining platform strategy across medical device products, and ensuring regulatory compliance (IEC 62304, ISO 14971, ISO 13485).

The ideal candidate has 10–12+ years of embedded firmware experience with RTOS, proven leadership, and a track record delivering

Qualifications

• 10+ years of embedded firmware experience with RTOS background.
• Experience leading teams and delivering regulated medical device software.
• Deep knowledge of IEC 62304, ISO 14971, ISO 13485 and related regulatory practices.

Responsibilities

• Build, lead, and grow two firmware pods: Safety & Platform; Systems & Integration.
• Own hiring, onboarding, performance management, and team retention.
• Serve as principal firmware technical authority across programs.
• Own IEC 62304 SDLC and ISO 14971 risk management sign-off.
• Drive resolution of field issues, CAPAs, and FSCAs.
• Establish firmware quality metrics and drive continuous improvement.
• Collaborate with Regulatory, Quality, and Clinical teams.

Skills

People leadership

Embedded firmware

RTOS

Firmware architecture

Regulatory knowledge

Stakeholder management

Education

B.E./B.Tech or M.Tech in Electronics, Embedded Systems, Biomedical Engineering, or Computer Science

Job description

Firmware Architect:

We are seeking an experienced Architect to lead the Firmware R&D team in a dual‑role capacity, combining people leadership with principal‑level technical expertise. The role is responsible for building and managing firmware engineering teams, defining the firmware platform strategy across medical device products, and ensuring compliance with regulatory standards. The ideal candidate will have 10 to 12+ years of embedded firmware with RTOS experience, including leadership of engineering teams and delivery of regulated medical device software. They should possess deep expertise in IEC 62304, ISO 14971, and ISO 13485, with a proven track record of driving firmware architecture, quality, risk management, and product development from concept through commercialization. Key strengths include team development, stakeholder management, regulatory compliance, technical decision‑making, and hands‑on embedded software development. Experience with FDA/CE‑regulated medical devices, audits, inspections, and global MedTech environments is highly preferred.

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.
• 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
• Drive resolution of critical field issues, CAPAs, and field safety corrective actions (FSCAs) as the
• 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
• 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.
• 10+ 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
• Experience leading teams through complete product development cycles from concept through commercial launch and post‑market sustaining.
• Demonstrated success growing engineers into senior and architect‑level contributors.