Location: MetroWest Region of Boston, MA
Overview
BrightSpec is a rapidly growing life science tools company launching a powerful, unique, and proprietary analytical platform. We are seeking an experienced Manufacturing / Test Engineer who will support the product development and production of our first-in-class Molecular Rotational Resonance (MRR) platform. This individual must demonstrate a strong track record of developing manufacturing assembly work instructions, test methods and procedures, and Design/process V&v activities to support our new MRR instrument product launches.
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… What you’ll do:
- 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.
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
About BrightSpec
Backed by leading venture capital investors, BrightSpec is an innovative life science tools company offering instruments that harness the power of molecular rotational resonance (MRR) spectroscopy. MRR enables rapid, unambiguous molecular ID and quantitative analysis of mixtures, without separation or chemometrics, and no reference samples are needed. BrightSpec is working with leading pharma, industrial, and academic groups to develop breakthrough methods that will enable important advances in Discovery, Manufacturing, and QAQC. The work is supported by a rising number of publications using BrightSpec instruments. With offices in Charlottesville, VA, and the MetroWest region of Boston, MA. BrightSpec is committed to a diverse workforce and offers competitive benefits. . Please submit your cover letter and resume to careers@brightspec.com.