Manufacturing Engineer IIApply Now
Location: Burlington, Massachusetts
Employment Type: Direct Hire
The Manufacturing Engineer II will provide technical floor support to instrument and consumable manufacturing operations to ensure on-time shipments of high-quality clinical and biotechnology products. In addition, the manufacturing engineer will work on process/product improvements as well as transfer of new products into manufacturing operations. The manufacturing engineer will also contribute to the investigation of technical issues in manufacturing to ensure continuous improvement.
- Provide day-to-day technical floor support to instrument/consumable operations by investigating and resolving issues which arise during the manufacturing of products.
- Measure/inspect electromechanical components for form, fit, and function and disposition nonconforming product.
- Update/create manufacturing documentation (SOPs, BOMs, forms and drawings) via the DCN process which conform to Quality System Regulations (QSR’s).
- Research, specify and procure new equipment for existing or new processes/assemblies. Design and construct tooling/fixtures for processes or modify existing production equipment as needed.
- Write and execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA) and Continuous Improvement Studies/Evaluations.
- Lead the transfer of new products and processes to manufacturing. Provide training to personnel on new products/processes as necessary. Contribute to continuous improvement programs to reduce cost and cycle times of products.
- Examine and implement lean manufacturing techniques.
- Bachelor’s Degree in Mechanical Engineering
- 2-5 years of manufacturing or mechanical engineering experience in a regulated industry; medical device experience is helpful
- Machine/Tool design experience
- Experience utilizing SolidWorks/SolidWorks PDM
- Knowledge of QSR and ISO regulations is a plus
- Good written and oral communication skills, including ability to communicate effectively at all levels of the organization
Yhoumey is a recruiter for our direct hire team. She enjoys partnering with candidates to find the right career placements.
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