Position Objective:
Responsible for providing process engineering support for all product manufacturing departments. Supports manufacturing operations to ensure consistent adherence to the standard operating procedures and business continuity. Initiates process improvement initiatives to improve the efficiency of current manufacturing processes, as well as develop new processes to improve manufacturing efficiency. Supports new product launches by collaborating with other functional areas and providing process engineering expertise during the implementation of processes or equipment.
Responsibilities:
Support Operations
- Successfully implement new products and processes.
- Reduce manufacturing errors and improvement of yields and cycle times.
- Incorporate feedback from Operations into the successful implementation of new processes or equipment.
- Troubleshoot equipment and processes through physical inspection/diagnosing of parts. Order replacement parts as needed.
- Incorporate best practices in the creation and improvement of Operations documentation.
- Revise equipment and part drawings and solid models.
- Provide Operations with clear procedures for new or changed equipment.
- Address supplier continuity issues to prevent product run-out.
Continuously Improve Processes and Equipment.
- Lead tasks or sub-projects within major product and process improvement initiatives.
- Coordinate Engineering Change Notices for design changes, including materials and process changes. (no managerial oversight)
- Provide engineering support for new equipment start-up, debug, and process validation. As required, develop, and conduct process evaluations and validations under guidance of senior engineers and quality engineering.
- Provide technical support when dealing with suppliers of key components and equipment.
Maintain and Improve Quality
- Contribute to the successful completion of audits by serving as a subject matter expert for assigned processes.
- Assist in audit deliverables and/or CAPA investigations and deliverables as assigned by management
Qualifications:- Master's degree with 2-4 years of equivalent experience, or bachelor's degree with 4-6 years of equivalent experience
- Degree in Engineering (Mechanical, Chemical, Biomedical, Industrial or related field of engineering)
- Data-Driven Problem Solving: Demonstrated understanding of problem-solving tools including; root cause analysis (5-why, fishbone) and Statistical process control (SPC), etc
- Process Optimization / Lean Mfg.: Demonstrated execution of lean principles, cycle time / throughput improvement, yield improvement, workflow optimization, etc.
- Cross-Functional Collaboration: ability to work cross-functionally with operators, quality, regulatory and management teams; train operators and implement new processes, etc.
Preferred Experience:- Green Belt in 5S/Lean Manufacturing
- Experience delivering automation of manual manufacturing processes.
- Experience in GMP/GDP manufacturing environments
- Experience troubleshooting industrial electronic hardware
- Experience supporting cleanroom processes (manual and automated)
- Experience supporting cleaning and sterilization processes
Benefits:
- Comprehensive Medical, Dental, and Vision
- Life Insurance
- Supplemental Benefits
- 401(k) with both Traditional and Roth options available
- Employee Stock Purchase Plan (ESPP)
- 10 Paid Company Holidays
- Competitive PTO plan
- Tuition Reimbursement
