Location: MetroWest Region of Boston, MA
BrightSpec is a rapidly growing life science tools company launching a powerful, unique, and proprietary analytical platform. We are seeking an experienced Senior Mechanical Engineer who will lead the product development of our first-in-class Molecular Rotational Resonance (MRR) platform. This individual must demonstrate a strong track record of mechanical design using solid-modeling CAD tools, detailed mechanical drawings and assembly drawings, and Design V&v activities to support our new MRR instrument product launches.
As a Senior Mechanical Engineer, you will lead all aspects of the mechanical design architecture of our instrument product development from conception to product launch release. This would include but not be limited to; mechanical layouts and design of electronic enclosures, EIA racks and frames, electronic packaging, power management cabling and cooling solutions. You will be developing Design Verification and Validation test methods, protocols, executing tests and writing reports necessary for new product release launches.
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:
- Lead the mechanical design, Verification & validation testing and release documentation of new instrumentation product line by designing electro-mechanical components, parts and assemblies.
- Design and validate designs per User Requirements to meet performance, cost, compliance and manufacturability targets.
- Create and maintain Design History Files; detail drawings, specifications, assembly drawings, Bill-of-Materials, manufacturing documents including Work Instructions and inspection criteria.
- Lead product design to meet their intended use. Ensure performance of engineering analyses to lead design decisions.
- Prepare and conduct Technical Design Reviews with cross-functional teams.
- Verify product 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 or Biomedical Engineering
- Minimum of 5 years relevant experience in designing electro-mechanical assemblies including sheet metal enclosures, EIA racks, control panels, mechanical layout of PCBAs, cable assemblies, machined parts and cosmetic dress panels
- Strong experience in solid-modeling CAD tools preferably SolidWorks, Pro/ENGINEER or CREO using PDM/PLM systems
- Strong experience in creating detail drawings using ASME Y14.5 standards and GD&T
- Hands-on experience designing, prototyping and testing of components and assemblies
- Strong Technical writing skills with 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:
- Design experience specifically of instrumentation products with spectroscopy components
- Program management experience using MS Project or Monday Gantt charts schedules, PMP/PMI certification is a plus
- Experience in a regulated design and manufacturing environment; ISO-9001, medical devices ISO-13485 and/or cGMP
- Familiar with Industrial Design concepts and renderings
- Familiar with UX and Usability requirements and studies
- Working knowledge of CAE analysis tools; FEA, CFD, MoldFlow
- Thermal design experience; thermal management and cooling of electronic components
- Design experience with microfluidics
- Experience with Design for Six Sigma, Lean Manufacturing, 5S and “Poka-yoke” principals, Six Sigma training or certification (Green Belt, Black Belt) is preferred
- Experience with various plastic part materials and fabrication methods; injection molding, extrusions, thermal-forming, urethane molded parts, Reactive Injection Molding
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 firstname.lastname@example.org.