Job Description

firstPRO is now accepting resumes for a Manufacturing Engineer role in Billerica, MA. This is a direct hire role and onsite. This is a second shift position 3pm to 11pm.

More specific responsibilities will include:

Floor Support

• Main responsibility is to provide technical support for all the manufacturing process equipment.
• Responsible for writing and updating the support documentation for the process
• Work with the Manufacturing Engineers and direct technicians to assist in troubleshooting and maintaining the manufacturing process equipment.

Prototype Build

• Participation in design reviews on new products during development phase.

Pilot & Production Build

• Manage technical resources consisting of engineers/technicians in the transfer of new processes and assemblies to manufacturing as well as providing cost estimates, creating work breakdown structures, creating/maintaining project schedules, providing project status reports, presentations of concerns/accomplishments to team and upper management.
• Manage the various functions of projects for proper implementation that meets all regulatory guidelines including the creation and performance of Installation, Operational & Performance Qualifications, Process Validations and Failure Mode Effects Analysis (FMEA).

Technical Functions

• Prioritize technical floor issues to resolve in a timely and efficient manner.
• Design fixtures and necessary tooling for processes or modifications to equipment as needed. This includes researching and finalizing specifications for capital equipment as well as supplier quote comparison and ROI analysis.
• Manage activities for continuous improvement to reduce product cost and cycle times.
• Create new manufacturing documentation and updating/enhancing existing documentation which conform to Quality System Regulations (QSR's) ISO Standards.
• Review and implementation of lean manufacturing techniques.
• Investigation of returned items from the field to determine root cause and implementing corrective/preventative actions to prevent reoccurrence.

Qualifications/Skills and Competencies:

• Must be proficient with Microsoft Office, (Solidworks and/or AutoCAD programs.
• Must have strong written and oral communication skills.
• Knowledge of FDA QSR's and ISO regulations is helpful.

Education/Experience:

• B.S in Mechanical Engineering/Biomedical/Electromechanical Engineering with 5-10 years of experience in the Biomedical or High Volume manufacturing field.
• Must have experience maintaining and troubleshooting complex high volume automated manufacturing equipment.

Job Tags

Similar Jobs