What are the responsibilities and job description for the Manufacturing Engineer position at Chronos Imaging LLC?
The ideal candidate possesses both a high level of technical expertise and an innate passion to build. You will play a critical role in creating and refining processes in order to improve manufacturing safety, quality, and productivity. You will provide engineering support to assigned manufacturing areas and product development teams to assure products, purchased parts and manufacturing processes consistently meet product requirements, customer expectations and regulatory requirements.
The manufacturing engineer is part of the Operations management team and drives continuous improvement in manufacturing efficiencies, quality, reliability, and product cost.
Key Duties & Job Responsibilities :
- Compliance with the Quality Management System and Environmental, Health & Safety requirements including being responsible for quality of work, good documentation practices / recordkeeping, good manufacturing practices (GMP) and safety.
- Document risk assessments for equipment that fails calibration.
- Lead / Implement process improvement activities.
- Monitor key performance indicators (KPIs) and lead quality improvements.
- Lead problem solving activities.
- Lead process / equipment and software validation activities.
- Lead daily activities of the nonconforming systems, including Engineering Review.
- Lead / Participate in regulatory audits and lead audit preparation.
- Lead / Participate in CAPA teams and complete in a timely manner.
- Supports in-sourcing / out-sourcing of component improvement activities.
- Perform evaluation of new designs and changes for conformance to requirements, manufacturability, and purchasing.
- Represent Manufacturing Engineering in New Product Introduction and ensures early Operations involvement
- Drives improvement and cost concept savings in new product development in close cooperation with R&D and Quality and Regulatory groups
- Effectively trains others in any or all components of job
- For controlled process, follow the current version of procedures and forms to perform work.
- Maintain a clean, safe, and orderly work area / environment.
- Other tasks and duties as assigned by hiring manager.
Competencies :
Physical Requirements :
