Equipment Engineer

Immediate opportunity with a top medical device manufacturing company located in the West Warwick, RI area! 6-12 month plus opportunity for an Equipment Engineering within the medical device industry! The right candidate will have minimum of 5 years experience, BSME and experience with manufacturing equipment engineering in a 24x7 production environment; (medical device industry, pharmaceuticals, biologics or related manufacturing processes preferred) A great opportunity for the right candidate with good medical experience to hit the ground running. Apply now for immediate consideration!!

RESPONSIBILITIES

- Provide on-going support for manufacturing related sterilization operations including process improvements, troubleshooting and maintenance practices of sterilization equipment and resolution of non-conformances
- Review internal non-conformances, investigate and implement corrective and preventive actions to ensure compliance to procedures and regulatory requirements
- Ensure compliance to site, Corporate, FDA, ISO, EN, and other regulatory requirements with regards to equipment maintenance
- Develop and maintain operating procedures and associated training material to ensure compliance with industry and regulatory standards
- Create, execute, and analyze experiments using statistical methods, including working with the process engineering and quality teams

REQUIREMENTS

- Bachelor's degree in mechanical engineering and experience in the medical device or pharmaceutical industry is strongly preferred
- 5 or more years experience with manufacturing equipment engineering in a 24x7 production environment; medical device industry, pharmaceuticals, biologics or related manufacturing processes
- Experience in sterilization, sterilization processes and validation requirements, including safety requirements
- Knowledge of PLC based process equipment, Building Management Systems (BMS) and Computerized Maintenance Management Systems (CMMS) as well as in-depth knowledge of government regulations, environmental regulations, and quality systems, particularly OSHA, FDA and ISO requirements
- Ability to read and understand PLC based control systems, P&ID and wiring schematics
- Knowledge of hazardous chemical handling, particularly related to EtO sterilization processing

BENEFITS