A Senior Staff Systems Engineer develops systems for in vitro diagnostic (IVD) instruments and accompanying laboratory automation. These medical devices provide rapid and accurate diagnostic testing for clinical laboratories around the world.
Responsibilities of the position include:
Leadership, mentoring, and/or technical oversight of 1 – 8 Systems Engineers
- Leads cross-functional engineering team (mechanical, electrical, chemical, software) utilizing project management skills.
- Manages team’s work scope
- Establishes team’s goals
- Reviews and critiques deliverables
- Design, plan and execute laboratory experiments to evaluate feasibility of concepts.
- Solve complex technical issues by troubleshooting, determining root cause, and then proposing design
- Define and develop System Architecture.
- Perform system modeling and analysis
- Translate customers’ needs into engineering requirements.
- Decompose and allocate System level requirements into Subsystem level requirements, ensuring complete
Design & Specifications
- Develop design and performance specifications.
- Develop system level control algorithms for optimized operation of the instrument.
- Develop design concepts to meet System requirements.
Verification and Validation
- Perform safety risk analysis to assure the safety and efficacy of the device.
- Perform technical/functional risk analysis to uncover engineering and project risks.
- Write verification and validation plans and protocols to effectively test designs against requirements and
Manufacturing and Customer Support
- Perform or oversee the execution of verification and validation testing.
- Review test data against established pass criteria.
- Write clear, data-driven technical summaries and test reports.
Master's or PhD Engineering Degree (Electrical, Mechanical, Systems, or Physics with 10+ years experience.
- Transfer designs to manufacturing facilities and support scale up.
- Provide engineering support for product launches and continued customer usage
FPCNational - 20 months ago