Manufacturing and Test Engineer

Job Title: Manufacturing and Test Engineer

Job Number: 32951

Location: Natick, MA

Job Description

As a Manufacturing and Test Engineer, you will be responsible for all aspects of manufacturing and test requirements to support the product release and production scale-up or our new instrumentation product lines.  This would include but not limited to writing assembly work instructions, assembly drawings, Bill-of-Materials, functional test methods and procedures, DFM/DFA analysis, working closely with our suppliers and Contract Manufacturers to scale-up production.

Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle a broad set of challenges as the company grows. This is an excellent opportunity for rapid career advancement in a fast-growing small company.

Responsibilities

• Develop, write and maintain manufacturing documentation for 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 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, 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, write and present design verification reports.
• Willingness to travel up to 20% to suppliers, CMOs and to our Charlottesville, VA facility.   

Required Skills

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