Senior Systems Engineer

Laborie Medical Technologies Corp • Portsmouth, NH

5d

About The Position

As a key member of the R&D team, the Senior Systems Engineer will lead the development of robust software and system requirements for medical devices, ensuring full compliance with FDA regulations and industry standards. This position is critical in driving risk management activities, supporting machine learning and data science initiatives, and collaborating across functions to enhance product performance and reliability. By applying deep expertise in systems engineering and regulatory compliance, the Senior Systems Engineer will play a key role in advancing Laborie’s mission to deliver innovative, high-quality medical solutions.

Requirements

• Bachelor's degree in Systems Engineering , Biomedical Engineering, Computer Science, Electrical Engineering, or a related field with at least 5-10 years of experience in systems engineering, with a focus on medical devices.
• Strong knowledge of FDA regulations, including 21 CFR Part 820, 21 CFR Part 11, and IEC 62304.
• Experience in software and system requirements development, risk management, and validation for medical devices.
• Demonstrated experience in process documentation, including software lifecycle management, per IEC 62304.

Nice To Haves

• Master's degree in a technical field.
• Experience or degree in data science / machine learning.

Responsibilities

• Develop Software, Hardware and System Requirements
• Perform Risk Management for Medical Devices
• Validate Non-Product Software to FDA Regulations
• Develop Process Documentation per IEC 62304

Benefits

• Paid time off and paid volunteer time
• Medical, Dental, Vision and Flexible Spending Account
• Health Savings Account with Company Funded Contributions
• 401k Retirement Plan with Company Match
• Parental Leave and Adoption Services
• Health and Wellness Programs and Events
• Awarded 2024 Cigna Healthy Workforce Designation Gold Level
• Laborie provides equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
• Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees