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H - Product Engineer 2 RECRUITED - 7M0066 - 100167
Ref No.: 14-01158
Location: Tarrytown, New York
The Systems Engineer has responsibility for instrument system development for in vitro diagnostic (IVD) instruments and accompanying laboratory automation. The medical devices provide rapid and accurate diagnostic testing for clinical laboratories working with hematology testing applications.

Responsibilities of the position may include:

Translate customers needs into engineering requirements.

Decompose and allocate System level requirements into Subsystem level requirements, ensuring complete traceability.

Assist and/or lead a cross-functional engineering team in developing design concepts to meet system requirements.

Write product, design and performance specifications.

Develop system level control algorithms for optimized operation of the instrument.

Write verification and validation plans and protocols to effectively test designs against requirements and customer needs.

Perform or oversee the execution of verification and validation testing.

Design, plan and execute laboratory experiments to evaluate system performance

Perform safety risk analysis to assure the safety and efficacy of the device.

Perform technical/functional risk analysis to uncover engineering and project risks.

Investigate and solve complex technical issues by troubleshooting, determining root cause, and proposing design modifications.

Review test data against established pass criteria.

Analyze results and communicate observations via clear verbal and written, data-driven technical summaries and reports.

Transfer designs to manufacturing facilities and support scale up.

Provide engineering support for commercial products.

The successful candidate will have a strong understanding of engineering fundamentals and how they can be applied across engineering, chemistry, and software disciplines, as well as an appreciation for the regulated medical device industry. He/she will be able to perform systems level analysis with an understanding of integration of the electro-mechanical, fluidics, reagents and software-controlled systems. The individual must function well both independently and as part of an integrated team. Effective verbal and written communication skills are essential. Familiarity with instrument manufacturing processes is helpful. Experience with requirements management tools is preferred, as is prior work with prototyping software and data collection tools, and system modeling tools such as finite element analysis.

The ideal background is in systems, biomedical, mechanical, or electrical engineering, with related experience in requirements, verification and validation. Work experience in the medical device industry or other regulated industry preferred