firstPRO is now accepting resumes for an Manufacturing Engineer role. This is a direct hire role and onsite everyday in Waltham, MA.
More specific responsibilities will include:
Provide day-to-day technical floor support to consumable operations by investigating and resolving issues which arise during the manufacturing/processing of products.
Measure/inspect components for form, fit, and function and disposition of nonconforming product.
Write MVs to document variances and circulate them for signatures.
Update/create all forms of manufacturing documentation which conform to Quality System Regulations (QSR's) and ISO standards.
Write and/or execute Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Validations, Design of Experiment (DOE), Process Failure Mode Effects Analysis (PFMEA), Process Validation Master Plans and Continuous Improvement Studies/Evaluations.
Lead inter-departmental projects to initiate new products and processes, improve existing processes, complete and release tests and validations, and other major tasks.
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.
Coordinate the transfer of new products to manufacturing. Collaborate with R&D and other manufacturing engineers to develop methods/processes to scale production. Train assemblers and operators regarding new processes and assemblies.
Qualifications:
- B.S. in Mechanical or Manufacturing Engineering is required.
- 6+ years of engineering experience and fundamental leadership experience are desired.
- Advanced proficiency with SolidWorks, Microsoft Office, Minitab, SAP, and Master Control.
- Knowledge of lean manufacturing methods and practices.
- Experience in leadership and guidance of technical professionals.
- Time and risk management skills.
- FDA QSR's and ISO regulations knowledge.
- Leadership and performance assessment skills.
- Project management skills.