The Systems Engineer works individually and with a cross –functional team to develop systems for in vitro diagnostic (IVD) instruments for point of care medical testing. These medical devices provide rapid and accurate diagnostic testing for point of care clinicians for the diagnosis and monitoring of patients with diabetes, kidney diseases, cardiac conditions, respiratory issues, critical care conditions, and other clinical applications.
• Main objective of this position will be a member of the engineering team that develops a new point of care analyzer as part of a new product development project within R&D
• This Systems Engineering role will be responsible for completion of a variety of tasks as assigned by the R&D project lead and is likely to include subsystem design and testing.
• This position will typically be part of a cross functional R&D team that has staff with multiple engineering and science disciplines, collaborating to accomplish complex system objectives.
Responsibilities of the position may include:
- Analyze instrument performance using a variety of commercial and custom tools.
- Perform system modeling and analysis.
- Assist in developing design concepts to meet System requirements
- Conduct tests of prototype system
- Design, plan and execute laboratory experiments to evaluate concepts and verify designs.
- Solve complex technical issues by troubleshooting, determining root cause, and then proposing design modifications.
- Assist in develop system level control algorithms for optimized operation of the instrument.
- Write, perform or oversee verification and validation plans and protocols to effectively test designs against requirements and customer needs.
- Review test data against established pass criteria.
- Write clear, data-driven technical summaries and test reports.
Bachelor (required); Masters (preferred) in Physical Science or Engineering (biomedical engineering, chemistry, physics, preferred fields)
0-5 years in biomedical/medical R & D (industrial or academic)
Good interpersonal skills
Good verbal and written communications – MS Word
Office tools such as MS Word, Excel
Knowledge of Matlab, Labview, Doors, and programming language such as VB, C, C++, C# a plus
The successful candidate will have a good understanding of engineering fundamentals. He/she will be able to perform systems thinking (big picture view). An understanding of electro-mechanical, precision, software-controlled systems is a plus. The individual must function well both independently and as part of an integrated team. Effective verbal and written communication skills are essential.
Supports the semi-complex planning of detailed product development objectives. Participates in the preparation of semi-complex sketches, design layouts, and other specifications. Provides support in semi-complex review of results to determine that products perform in the intended manner. Participates in preparing semi-complex prototypes for testing and provides technical assistance on design feasibility. Assists in standardizing semi-complex materials, components and assemblies. Participates in maintaining detailed and comprehensive records of all inventive ideas, designs, and basic improvements. Provides support in documenting product issues for future reference and problem resolution.