Volt is seeking an Engineering Manager for a great opportunity with a rapidly growing Medical Device company in the Boston, MA area!
- Supervises and leads Manufacturing Engineers and Technicians. Assigns projects, monitors results, and provides support and feedback.
- Develops and executes Goals & Objectives and metrics for the Mfg Engr department.
- Manages all equipment used in the Boston manufacturing processes, including equipment design & development, equipment selection, equipment upgrades, equipment troubleshooting & repairs, and supplier selections related to equipment and mfg facility.
- Identifies manufacturing process improvements, analyzes solutions, and implements best options.
- Identifies and implements all capital equipment requirements.
- Leads and develops process qualification programs for all plant processes and equipment. Provides oversight to team to write and approve protocols and reports, analyze test results, and recommend actions.
- Participates in ERP system data development and management supporting data verification and maintenance used in the production environment.
- Supports all sustaining engineering activities for products manufactured in the plant.
- Supports NPI product transfer activities into manufacturing with an emphasis on manufacturability and process scale-up.
- Bachelor of Science degree in an Engineering discipline is required. Master of Science in Engineering and/or MBA is preferred.
- Experience in an engineering and/or manufacturing environment is required - minimum 10 years with BS degree or 7 years with MS degree.
- Experience in the medical device industry is preferred.
- Knowledge of ISO13485 Design Control and its application in the manufacturing environment is preferred.
- Knowledge of equipment process validation requirements, lean manufacturing techniques, and manufacturing equipment design and operation is required.
- Familiarity with mechanical and automated systems is required.
- Ability to work in a smaller hands-on environment is preferred
- Six Sigma and Lean Mfg certifications are preferred.
- Ability to develop and write Work Instructions and Standard Operating Procedures that are compliant to medical device industry standards is required.
- Demonstrated leadership ability to lead a team of engineers is required. Must be able to give and receive constructive feedback; contribute to building a positive team environment.
Volt is an equal opportunity employer.