What are the responsibilities and job description for the Senior Systems Engineer position at Laborie?
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 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.
About The Role
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.
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 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.
About The Role
- 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
- 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. Bullet 2
- Master's degree in a technical field.
- Experience or degree in data science / machine learning.
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
- Awarded 2024 Cigna Healthy Workforce Designation Gold Level
