Firmware Architect

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.