Sr Engineer II, Algorithm

Job Summary:

The Senior Engineer II, Algorithm (ECG) is a senior-level individual contributor responsible for architecting, developing, validating, and optimizing advanced ECG-based signal processing algorithms for Masimo's non-invasive medical device platforms.

This role provides technical leadership in the design and deployment of robust, real-time cardiac monitoring algorithms across the full product lifecycle - from early feasibility and system architecture through embedded implementation, verification, regulatory submission, and post-market optimization. The Senior Engineer II serves as a subject matter expert in ECG signal processing, mentors junior engineers, and influences system-level design decisions to ensure clinically meaningful, high-performance, and regulatory-compliant solutions.

Duties & Responsibilities:

• Architect, design, and optimize advanced ECG signal processing algorithms for cardiac monitoring applications, including arrhythmia detection, morphology analysis, interval measurement, heart rate variability, and multi-lead signal interpretation.
• Develop scalable signal conditioning, filtering, artifact rejection, motion compensation, and feature extraction methods suitable for real-time embedded deployment.
• Lead feasibility investigations and contribute to next-generation ECG feature development and measurement technologies.
• Translate clinical needs and system requirements into algorithm specifications, performance targets, and verification strategies.
• Implement and optimize algorithms in MATLAB and production-level C/C++ for embedded systems, ensuring computational efficiency, memory optimization, and real-time performance on constrained hardware platforms.
• Collaborate closely with firmware, hardware, and systems engineering teams to ensure seamless system-level integration and performance robustness.
• Lead large-scale clinical dataset analysis to evaluate algorithm accuracy, robustness, and reproducibility across diverse patient populations and signal conditions.
• Apply advanced statistical modeling and, where appropriate, machine learning techniques to enhance detection performance and minimize false positives and negatives.
• Develop and execute validation protocols, define performance metrics, and document verification results in compliance with FDA QSR (21 CFR Part 820), ISO 13485, and global regulatory requirements.
• Support risk management activities in accordance with ISO 14971, including hazard analysis, failure mode identification, and mitigation strategies.
• Contribute to regulatory submissions and technical documentation, and participate in design reviews, audits, and inspection readiness activities.
• Serve as a technical mentor to junior engineers and provide subject matter expertise in ECG algorithm development across multiple programs.
• Analyze post-market data and complaint trends to identify algorithm improvement opportunities and lead root cause investigations related to field performance.
• Contribute to intellectual property development, including invention disclosures and patent support where applicable.

Minimum Qualifications:

• Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, Computer Engineering, Applied Mathematics, or related technical discipline.
• 7+ years of experience in biomedical signal processing, including significant hands-on ECG waveform analysis experience.
• Deep expertise in digital signal processing, statistical modeling, and algorithm optimization.
• Strong proficiency in MATLAB and C/C++ for real-time embedded deployment.
• Demonstrated experience translating research algorithms into production-ready embedded solutions.
• Experience analyzing large-scale physiological datasets.
• Strong understanding of medical device design controls and regulatory frameworks.
• Proven ability to independently lead complex technical initiatives.
• Ability work onsite Monday - Friday in Irvine, CA.

Preferred Qualifications:

• Advanced degree (M.S. or Ph.D.) in Electrical Engineering, Biomedical Engineering, or related field.
• Experience developing algorithms for multi-parameter cardiac monitoring systems.
• Experience applying machine learning to ECG or physiological signal classification.
• Familiarity with IEC 60601 standards and cardiac monitoring regulatory pathways.
• Experience supporting clinical studies and regulatory submissions.

Education:

Bachelor's degree required; Master's or Ph.D. preferred in Electrical Engineering, Biomedical Engineering, or related discipline.

Compensation:

The anticipated salary range for this position is $139,000 - $185k plus benefits. Actual placement within this range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on company, department, and individual performance.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.