BIT Group is seeking an Industrial Engineering, who will be responsible for managing the quality and reliability performance of assigned products, accessories and spares by applying industry standard quality and manufacturing.
ABOUT THE COMPANY:
BIT Group is the leading resource for turnkey development and manufacturing of IVD instrumentation and complex life science products. Our senior staff members have an average of fifteen years’ experience in the industry, each with a long history of successfully developing and manufacturing medical devices, in vitro diagnostic instruments and bioresearch platforms.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Drives manufacturing quality and continuous improvement efforts.
- Works one-on-one with specific disciplines and /or suppliers as needed to engage the stakeholder and achieve needed quality and/or vendor(s) to correct negative trends.
- Interfaces with project managers, customer service, clients/partners and/or users to provide quality and reliability trend information and specific reports, as required.
- Work under the direction of other Industrial engineers and the Industrial engineering manager to:
- Prepare and route engineering change request and change orders o Verify engineering change order implementation
- Assist with development and implementation of new work cells
- Fill out purchase requisitions to support work cells or prototype build
- Create part numbers and enter data in ERP
- Update assembly and test procedures
- Assist with troubleshooting instruments
- Assist with CAPA’s and root cause analysis
- Assist with prototype assembly and test
- Assist with process risk analysis
- Fill out planned deviation request
- BS in any of these related technical fields: industrial, mechanical, electrical, mechatronics, bio-medical, or software with interest in manufacturing.
- 1-5 years’ experience including knowledge and use of regulatory guidelines such as FDA, ISO 13485, and Standard company quality system requirements preferred.
- Highly organized - Excellent follow through and follow up skills; results and delivery oriented
- Ability to keep track and on top of multiple duties and work related requests
- Self-motivated and works well under pressure with changing priorities and a workload
- Team player with very good collaboration skills, fostering knowledge sharing with team members
- Exceptional communication and documentation skills
- Willingness to work extended hours as required to meet company objectives
- BIT Group is committed to hiring and retaining a diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action-Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.