Senior Systems Engineer

We believe that great healthcare is an essential safeguard of human dignity.

At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.

We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.

Who We’re Looking For:

As a key member of the R&D team, the Senior Systems Engineer will be responsible for creating software and system requirements, ensuring compliance with FDA regulations, performing risk management activities, and supporting machine learning and data science initiatives related to medical devices.

About the Role:

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

Minimum Qualifications:

• Bachelor’s degree in systems engineering, biomedical engineering, computer science, electrical engineering, or a related field and 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.

Preferred Qualifications:

• Master's degree in technical field.
• Experience or degree in data science / machine learning.
• Experience with software validation tools and platforms for medical devices.
• Knowledge of cloud-based data analytics platforms and AI/ML infrastructure.

Why Laborie:

Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries. 

• 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

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.