What are the responsibilities and job description for the System Engineer position at Fusion Life Sciences Technologies LLC?
Job Title: Senior Lead Systems Engineer
Location: Hybrid Onsite in Arden Hills, MN
Duration: 12 Months Extensions
About the Role: Our client is seeking a Systems Engineer with a strong background in Electrical or Computer Systems Engineering to join our innovative medical device team. This role requires a professional with a minimum of 5 years of experience in the medical device industry. The ideal candidate will be responsible for providing technical assessments, recommendations, and insights to ensure the design and performance of medical devices meet stringent industry standards and user requirements, particularly from a Bluetooth/BLE and RF perspective.
Key Responsibilities:
- System Design & Integration:
- Lead and collaborate on the design, development, and integration of electrical and computer systems within medical devices.
- Ensure system-level design meets functional, performance, and safety requirements for medical applications.
- Bluetooth/BLE Testing & RF Analysis:
- Conduct Bluetooth/BLE testing, validation, and troubleshooting to ensure reliable wireless communication within medical devices.
- Assess RF performance and ensure compliance with regulatory requirements for safe usage in clinical environments.
- Provide feedback and recommendations to the design team regarding RF, BLE/Bluetooth challenges, and issues.
- End-to-End Product Understanding:
- Develop a comprehensive understanding of the product's complete lifecycle, including its interaction with other systems and how it will be used in real-world medical settings.
- Translate system-level requirements into technical specifications and actionable insights.
- Systems Verification & Validation:
- Lead verification and validation (V&V) processes to ensure that systems meet all functional, regulatory, and performance requirements.
- Define, develop, and execute test plans to validate system performance and safety.
- Characterize system behavior through rigorous testing, data analysis, and optimization efforts.
- Problem Solving & Design Feedback:
- Serve as a technical expert in diagnosing system issues and providing actionable feedback to the design and development teams.
- Perform root cause analysis of design problems and provide corrective action recommendations.
- Regulatory Compliance & Documentation:
- Ensure all systems comply with medical device regulations and standards (FDA, ISO, etc.).
- Prepare technical reports, documentation, and regulatory submissions as needed.
Qualifications:
- Bachelor's or Master's degree in Electrical Engineering, Computer Systems Engineering, or related field.
- Minimum of 5 years of experience in the medical device industry.
- Proficiency in Bluetooth and Bluetooth Low Energy (BLE) technologies, including testing and validation.
- Strong understanding of RF systems, including RF protocols and their integration into medical devices.
- Experience with systems verification and validation processes in the medical device sector.
- Solid understanding of systems engineering principles, especially within the context of medical devices.
- Ability to assess complex systems, characterize performance, and recommend improvements.
- Strong problem-solving skills with experience providing critical feedback to design teams.
