Nova Biomedical is hiring a Manufacturing Engineer Ill to provide technical support for manufacturing operations regarding various processes and assembly issues. As the Manufacturing Engineer III, you will contribute to or lead development, design, and the validation of existing and start up manufacturing equipment and/or processes. You will have responsibility for writing and updating support documentation, performing IQ, OQ and VQ's.
More specific responsibilities will include:
- 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 and direct the Manufacturing Engineers and technicians to assist in troubleshooting and maintaining the manufacturing process equipment.
- 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).
- 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 engineering 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.
- Program management of OEM product for all technical and manufacturing aspects of the client's program.
- 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.
- Train and or oversee the training of employees on new products, equipment, and processes.
- Document training records.
- Demonstrate the use of the equipment to visitors.
- B.S/M.S. in Mechanical Engineering/Biomedical Engineering with 5-10 years of experience.
- Must be proficient with Microsoft Office, (Solid works a plus) and AutoCAD programs.
- Strong written and oral communication skills.
- Knowledge of FDA QSR's and ISO regulations is helpful.
At Nova Biomedical, we practice our core values of mutual respect, honesty, and integrity throughout the company. With a strong sense of family in the workplace, we are proud that one third of all our employees have been with us for over 10 years.
Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, company subsidized cafeteria and an innovative scholarship program for children of employees.
How To Apply
Please email your resume to firstname.lastname@example.org for consideration