Manufacturing and Test Engineer

• Develop, write, and maintain manufacturing documentation for the new instrumentation platform, including; assembly Work Instructions, assembly drawings, and Bill-of-Materials
• Develop and document functional test methods and procedures for PCBAs and electronic enclosures consisting of power supplies, controllers, microwave amplifiers, cables assemblies, and various electro-mechanical components
• Conduct DFM/DFA analysis working with our development team and with our suppliers and Contract Manufacturers to ensure best practices for efficient assembly and test methods to scale up production with the highest quality and repeatability
• Create and maintain Design History Files; detail drawings, specifications, assembly drawings, Bill-of-Materials, and manufacturing documents, including Work Instructions and inspection criteria
• Participate in Technical Design Reviews with cross-functional teams
• Verify product testing and performance against design inputs. Write verification protocols, perform testing, analyze and interpret test data, and write and present design verification reports
• Willingness to travel up to 20% to suppliers, CMOs,, and our Charlottesville, VA facility

Qualifications… Must Haves:

• Bachelor’s degree in either Mechanical Engineering, Electrical Engineering, Biomedical Engineering or equivalent
• Minimum of 2 years relevant experience in developing the assembly process and testing procedures of electro-mechanical assemblies including PCBAs, power supplies, controllers, cable assemblies and various components
• Familiar with detail drawings using ASME Y14.5 standards and GD&T
• Hands-on experience in building prototypes and testing of components and assemblies
• Technical writing of Design Verification & Validation protocols and reports
• Proficient with Microsoft Office tools; Word, Excel, Power Point, Project and Visio.
• Familiar with various materials and fabrication methods such as; sheet metal fabrication, CCN machining, die-casting, cosmetic parts using thermal-forming, urethane molds and RIM

Desirable… Good to Haves:

• Manufacturing and testing experience specifically of instrumentation products with spectroscopy components or similar instruments
• Experience in solid-modeling CAD tools preferably SolidWorks, Pro/ENGINEER or CREO using PDM/PLM systems
• Knowledge of PCBA design and test methods; flying probe, functional tests and In-Circuit Tests
• Experience with Design for Six Sigma, Lean Manufacturing, 5S and “Poka-yoke” principals, Six Sigma training or certification (Green Belt, Black Belt) is preferred
• Program management experience using MS Project or Monday Gantt charts schedules, PMP/PMI certification is a plus
• Experience in a regulated manufacturing environment; ISO-9001, medical devices ISO-13485 and/or cGMP