This engineer works within a project team – generally in collaboration with a Project Manager. This engineer uses experience and education to perform the types of engineering activities which are generally considered within the realm of systems engineering, integrating electrical, mechanical, and firmware designs, and any other expertise that might be held by this particular individual. This engineer is expected to work and communicate well with other team members and leaders to ensure instrument engineering activities of the company are accomplished in accordance with Biomerieux’s quality system.

Primary Duties:

• Uses engineering concepts, company SOPs/WIDs, department SOPs/WIDs to solve a variety of engineering problems across functional groups and disciplines.

• Works on projects of limited to moderate scope and complexity. Generally works with a team of engineers.

• Works in collaboration with a senior Systems Engineer, engineering lead, and/or Project Manager, provides technical contributions on a project.

• Interfaces with engineers, designers, technicians, and specialists of multiple disciplines to ensure that system level design objectives are met and conform to requirements.

• Works with engineers to resolve technical issues associated with design and implementation of the system.

• Contributes to the Engineering Risk Analysis, product (and/or process) requirements, product (and/or process) verification, high-level block diagram, and the verification plan with the Project Manager and in collaboration with project leads.

• Attends project technical reviews. Reviews project documents for technical content.

• Attends risk analysis meetings, reviews FMEAs, and ensures risk mitigation and translation into specifications.

• Evaluate subsystems and subassemblies against system requirements. Ensures proper subsystem and subassembly interfaces.

• Ensures compliance to standards and regulations (e.g. UL, CE, FDA, ISO).

• Contributes technical content to the the Design History File and the Device Master Record.

• May write the product (and/or process) level Change Notifications and associated summary and Change Order supporting Instrument release.

• Perform all work in compliance with company policy and ensures all project documents comply with company policy and within the guidelines of Biomerieux Quality System.

  Training and Education:

  B.S. in Engineering or Equivalent

  Experience:

  0-2 years of experience in related field, including performance consistent with said experience

  Knowledge, Skills and Abilities:

  Experience with the following is preferred:

• Risk Analysis (e.g., FMEA)

• Electromechanical Systems Integration

• Software Systems Integration

• Requirements creation

• Data Analytics (e.g. Six Sigma)

• Test-Driven Development

• Electrical Design (e.g, Schematic Capture, PCB Layout, Analog Circuit Design, Digital Circuit Design, Control Systems)

• Mechanical Design (e.g. Solidworks, Plastics design, Optics design, sheet metal design, molding processes, materials, pneumatics, machining esp. CNC, GD&T)

• Molecular Biology (e.g. PCR)

• Compliancy (ISO 13485, CE, UL, FCC, RoHS)