Systems Engineer I/Ii

Description

Position Summary:

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 design as part of a molecular diagnostic system design., 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 leads to ensure instrument product development activities of the company are accomplished in accordance with BioFire’s quality system.

Responsibilities:

• Description: Uses engineering concepts, company SOPs/WIDs, department SOPs/WIDs to solve a variety of complex engineering problems across functional groups and disciplines.
• General: uses experience and education to perform the types of engineering activities which are generally considered within the realm of systems engineering.

• Determines the overall technical direction and architecture for the project with management to ensure solution meets corporate / strategic vision for the project.
• Evaluate subsystems and subassemblies against system requirements. Ensures proper subsystem and subassembly interfaces.
• System Engineering:
• Responsible Contributes technical content to for the technical aspects of the Design History File and the Device Master Record.
• Ensures compliance to standards and regulations (e.g. UL, CE, FDA, ISO).
• Attends risk analysis meetings, reviews FMEAs, and works with project team to ensures appropriate risk mitigation and translation into specifications.
• Works on: projects of limited to moderate scope and complexity. Generally works with a team of engineers.
• Attends project technical reviews. Reviews project documents for technical content.
• Writes 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 other project leads.
• Contributes to product (and/or process) level Design Change Notice Notifications and associated summary and Change Order supporting Instrument release.
• Works with engineers to resolve technical issues associated with design and implementation of the system.
• Influence: works in collaboration with a senior Systems Engineer, engineering lead, and/or Project Manager, and provides oversight and guidance to project engineers.
• Compliance: Perform all work in compliance with company policy and ensures all project documents comply with company policy and within the guidelines of BioFire Diagnostics Quality System.
• Supports the creation of the project Work Breakdown Structure in collaboration with the Project Manager. Assists the Project Manager with stakeholder identification.
• Interfaces with engineers, designers, technicians, and specialists of multiple disciplines to ensure that system-level design objectives are met and conform to requirements.

Principal Decisions:

Leads projects technically by consulting consult with engineering leads and making data-based project recommendations and decisions subject to senior engineer oversight. Assists in making final project decisions, subject to review by the Project Manager and Engineering Management.

Implements mitigation to evaluated design and process risks and provides translation into design and process specifications. Reviews all assigned technical aspects of the project and makes contributes to determinations regarding system risks.

Supplemental Data:

Travel: minimal travel required.

Team: usually works on a team with several engineers and a Project Manager.

Qualifications:

Training and Education:

B.S. in Engineering or Equivalent

Experience: 0-2 years of experience for a level I 2-5 years of experience for a level II in a related field, including performance consistent with said experience as applicable.

Skills and Qualifications:

• Compliancy (CE, UL, FCC, RoHS)
• Mechanical Design (e.g. Solidworks, Plastics design, Optics design, sheet metal design, molding processes, materials, pneumatics, machining esp. CNC, GD&T
• Biomedical Engineering
• Test-Driven Development
• Data Analytics (e.g. Six Sigma)
• Electromechanical Systems Integration
• Requirements creation and management
• Resource Allocation and Project Scheduling
• Electrical Design (e.g, Schematic Capture, PCB Layout, Analog Circuit Design, Digital Circuit Design, Control Systems)
• Software Systems Integration
• Risk Analysis (e.g., FMEA)

Physical Requirements:

Able to safely lift 50 pounds.