Embedded Firmware Architect

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.

• 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.

• 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

to design history files.

• 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.