Principal Software Engineer

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Life Sciences & Pharma Recruiter @Intellectt Inc

Job Title: : Principal Software or Systems Engineer - Medical Device

Note: No C2C - Only W2

Key Responsibilities

• Lead the architecture, design, and implementation of bare-metal and RTOS-based embedded systems in C for Class III medical devices.
• Drive full system integration including sensor interfacing, hardware abstraction layers, and hardware-software synchronization.
• Collaborate with electrical engineering teams on board bring-up, schematic reviews, and hardware debugging.
• Perform real-time system analysis to ensure deterministic performance in safety-critical applications.
• Author and review design documentation in compliance with FDA, ISO 13485, IEC 62304, and other applicable regulatory standards.
• Conduct code reviews, risk analysis, and design verification in alignment with regulatory and quality requirements.
• Mentor junior engineers and provide technical leadership across the embedded systems team.
• Work with test engineering to develop verification and validation strategies for embedded software.

Required Qualifications

• 10+ years of experience in embedded systems development (exceptional candidates with 6+ years will be considered).
• Proven expertise in Embedded C programming for bare-metal and RTOS platforms.
• Strong electrical engineering background—capable of reading schematics, understanding board-level design, and debugging hardware.
• Hands-on experience with sensor integration, hardware peripherals, and low-level drivers.
• Familiarity with real-time systems, deterministic scheduling, and interrupt-driven designs.
• Experience in safety-critical, regulated environments (preferably Class III medical devices).
• Knowledge of applicable standards such as IEC 62304, ISO 14971, ISO 13485, and FDA 21 CFR Part 11/820.

Preferred Qualifications

• Master’s or Ph.D. in Electrical Engineering, Biomedical Engineering, Computer Engineering, or related field.
• Advanced coursework or thesis in embedded systems, real-time systems, or medical device design.
• Familiarity with medical device development lifecycle from concept to post-market support.
• Experience with unit testing, integration testing, and automated test frameworks for embedded systems

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Engineering, Design, and Quality Assurance

• Industries

  Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research

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