The System Engineer II will be part of the system development team focusing on the development of an IVD prenatal diagnostics and screening system. The individual will be part of a team tasked with the development of an automated system for an innovative Non-Invasive Prenatal Test (NIPT) in collaboration with both internal partners and external OEM vendors.
- Expertise in medical device design and development is essential.
- Experience in designing and execution of test cases to verify hardware, software and system performance.
- Nucleic acid based diagnostics technology background and next-generation sequencing experience are highly desirable.
- Works under general supervision, to conduct and monitor laboratory experiments utilizing established and published procedures, and technical and theoretical understanding.
- Hands-on with a strong instrument/platform development background, the candidate will be asked to troubleshoot systems, identify opportunities for quality improvements, provide root causes of complex HW-SW interaction problems, and communicate test results and corrective recommendations to the team.
- Summarizes experimental results, and reviews conclusions with supervisor/project leader
- Communicates results of experiments in the form of reports and presentations
- Performs work according to established internal safety guidelines and procedures, and as specified by appropriate external regulatory agencies (e.g. OSHA)
- Assesses results for applicability, validity, and conformance to Product Requirements
- Works independently with general management direction. Work is reviewed in detail over a specific time frame.
- Writes test cases, and implements and executes automated tests to verify the hardware, software and system performance.
- He or she will work closely with external and internal design teams to understand and resolve product performance issues.