Systems Engineer II - LABORIE Medical Technologies : Job Details
Systems Engineer II
LABORIE Medical TechnologiesJob Location : Portsmouth,NH, USA
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: We are seeking a highly skilled and detail-oriented Systems Engineer II to join our R&D team. The successful candidate will play a crucial role in the development and lifecycle management of cutting-edge medical devices. You will work cross-functionally with product development, regulatory, and quality teams to ensure system integration, reliability, and compliance with industry standards. This role requires strong analytical and problem-solving skills to develop innovative solutions for complex engineering challenges. About the Role:
- System Design & Integration: architecture and integration of hardware, software, and mechanical systems for medical devices, ensuring seamless interoperability and performance.
- Requirements Development: Collaborate with stakeholders (R&D, regulatory, clinical, etc.) to define system requirements, ensuring all technical specifications are met and aligned with regulatory standards.
- Risk Management: Conduct risk assessments and failure mode and effects analysis (FMEA) to ensure system safety, reliability, and compliance with medical device standards (ISO 14971, IEC 60601, etc.).
- Verification & Validation: Design and execute test protocols for system verification and validation to ensure products meet design specifications and regulatory requirements.
- Documentation: Prepare and maintain detailed technical documentation, including system architecture, requirements traceability, and test reports to support regulatory submissions (FDA, CE Mark, etc.).
- Cross-Functional Collaboration: Work closely with software, hardware, and mechanical engineering teams to ensure the proper integration of system components.
- Compliance: Ensure designs and processes comply with medical device regulations and quality standards (e.g., FDA, ISO 13485, and IEC 62304).
- Lifecycle Management: Provide ongoing support for product lifecycle management, including troubleshooting, sustaining engineering, and post-market surveillance.
- Continuous Improvement: Drive continuous improvement initiatives within systems engineering processes to enhance product performance and reliability.
- Bachelor's degree in Systems Engineering, Electrical Engineering, Biomedical Engineering, or a related technical field, and 5+ years of experience in systems engineering, preferably within the medical device industry. Master's degree and a minimum of 3 years of experience.
- Experience with medical device product development from concept to commercialization.
- Familiarity with FDA regulations and ISO standards (ISO 13485, ISO 14971, IEC 60601, etc.).
- Knowledge of embedded systems and software development processes (e.g., IEC 62304).
- Experience with medical device risk management, usability engineering, and human factors.
- 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 2023 Cigna Healthy Workforce Designation Gold Level