Description

Position Summary:

This engineer works within a project team – generally under the leadership of a more experienced individual (e.g. senior/principal engineer, systems engineer, and/or project manager). This engineer uses experience and education to perform the types of engineering activities which are generally considered within the realm of mechanical engineering and any other expertise that might be held by this particular individual. The successful candidate will possess an in-depth knowledge of mechanical design, robotics, end effector design, pneumatic and safety system design with regards to automated manufacturing. This engineer is expected to work and communicate well with other team members and leadership as assigned in order to meet the goals of the project, the department, and the company.

Principal Job Duties and Responsibilities:

• General: Uses experience and education to perform the types of engineering activities which are generally considered within the realm of mechanical engineering and automation systems in an FDA-controlled facility.
• Description: Uses engineering concepts, company and department SOPs/WIDs to solve a variety of complex engineering problems across functional groups and disciplines.
• Works on: Problems of significant scope and complexity. May architect system designs and solutions. Generally works on a team with other engineers.
• Influence: Receives some oversight from a Senior or Principal Engineer, eligible to be a discipline lead on a project, may provide mentoring for other engineers, and may provide limited department management and leadership.
• Compliance: Learns and understands the products and manufacturing processes at Biofire Diagnostics. Performs all work in compliance with company policy and within the guidelines of BioFire Diagnostics Quality System. Participates in machine risk assessments in accordance with ISO 12100.

Principal Decisions:

Makes design and technical decisions subject to review by Senior, Principal, and other engineers.

Supplemental Data:

• Travel: minimal travel required.
• Team: usually works on a team with several engineers and a project manager.

Qualifications

Training and Education:

• Requires a B.S. in Mechanical, Mechatronic, or Manufacturing Engineering or equivalent.

Experience:

• 5 to 10 years of experience in related field, including performance consistent with said experience.
• Experience working to regulatory standards: FDA (ISO 13485), Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP).

Skills:

• Experience with the following is preferred:
  • Design for high volume production
  • Knowledge regarding application of robotics, material movement systems, and complex assembly cells
  • Six Sigma Green Belt and Lean principles
  • SolidWorks
  • SolidWorks Simulation
  • Heat transfer
  • Molding processes
  • Materials (e.g. plastics, aluminum, copper, steel, etc.)
  • Pneumatics
  • GD&T

Physical Requirements:

Able to safely lift 50 pounds.