Manufacturing Engineering - Sustaining Engineer
Job ID :
US - California - Fremont
Sustaining Engineer Job Description
- Support Operations management requirements to achieve target levels of customer service.
- Develop, implement, and maintain manufacturing processes and the related documentation required to manufacture every product within its specifications, schedule, and budget.
- Assess equipment status and identify risk of obsolescence, upgrade needs or potential productivity gains. Evaluate and implement necessary upgrades to maintain a world-class manufacturing environment.
- Identify work related hazards and assist with the implementation of safer alternatives.
- Assist the Facilities Department on complex mechanical failures and determination of appropriate preventive maintenance activities.
- Participate in production daily meeting to resolve current equipment and process issues.
- Support the validation of new and modified manufacturing equipment, processes and materials.
- Provide hands-on sustaining engineering efforts to develop and improve manufacturing process.
- Provide engineering support to improve product manufacturing first pass yield and quality concerns.
- Seek PPI Project opportunities for improvements in key measurement areas (speed, cost, quality, and productivity). Drive high dollar product quality projects that produce significant value for the business through sustaining engineering activities.
- Work in concert with the Manufacturing and Facilities departments to identify, correct, and prevent equipment reliability issues.
- Work with the Manufacturing and Quality departments to develop and train on standard operating procedures and work instructions.
- Maintain and ensure systems and procedures are compliant with regulatory requirements and Thermo Fisher Scientific policies and procedures.
- Bachelor Degree in an engineering science. Mechanical engineering preferred.
- 5 years of experience in the cGMP regulated industry. In-vitro diagnostic experience preferred.
- 5 years of experience Sustaining Engineering, Manufacturing Engineering or Quality Engineering.
- Mechanical understanding of equipment typically used in the biotech industry.
- Demonstrated experience with Lean Manufacturing principles.
- Ability to perform failure investigation.
- Experience with SolidWorks and AutoCAD.
- Understanding of QSR and ISO 13485 requirements.
- Good analytical skills and ability to communicate effectively with all levels.
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