Katalyst CRO · 2 days ago
Embedded Software Engineer- 2
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expKatalyst CRO is a company focusing on software development in the medical device industry. They are seeking a Senior Embedded Software Engineer to develop and document embedded software for FDA-regulated medical devices.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Bachelor's or master's degree in computer science, Electrical Engineering, or a related field
8+ years of professional software development experience, preferably in the medical device or regulated industry
Experience working with electro-pneumatic or electromechanical devices involving interfaces with actuators, sensors, and fluid or flow control systems
Experience developing embedded software for microcontroller-based systems (e.g., STM32, NXP, TI) and working with communication protocols such as UART, SPI, I2C, and CAN
Experience with unit testing, static analysis, code reviews, and system integration testing in a structured SDLC environment
Practical experience developing and documenting embedded software for FDA-regulated Class B and Class C medical device software
Working knowledge of relevant standards including IEC 62304 (software life cycle), ISO 14971 (risk management), and FDA medical device software guidance
Qualification
Required
Bachelor's or master's degree in computer science, Electrical Engineering, or a related field
8+ years of professional software development experience, preferably in the medical device or regulated industry
Experience working with electro-pneumatic or electromechanical devices involving interfaces with actuators, sensors, and fluid or flow control systems
Experience developing embedded software for microcontroller-based systems (e.g., STM32, NXP, TI) and working with communication protocols such as UART, SPI, I2C, and CAN
Experience with unit testing, static analysis, code reviews, and system integration testing in a structured SDLC environment
Practical experience developing and documenting embedded software for FDA-regulated Class B and Class C medical device software
Working knowledge of relevant standards including IEC 62304 (software life cycle), ISO 14971 (risk management), and FDA medical device software guidance
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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