Manufacturing Process Engineer
Description
Supports the manufacturing of Rani Capsules. Works with engineering and clinical to ensure device specifications conform to device requirements. Responsible for establishing baseline by evaluating the current manufacturing processes and making improvements to increase productivity, quality /reliability, and reduce cost and scrap
Requirements
- Evaluate the current manufacturing processes /workflows to identify opportunities for improving productivity and quality while reducing cost /labor
- Perform process capability studies via DOE’s. Utilize statistical data analysis to arrive at sound conclusions and follow up with action plan for process improvements
- Develop standards and monitoring techniques to reduce variability in manufacturing that may include operator, material, equipment and processes
- Actively participate in discussions with appropriate functions and contribute to new initiatives that may include design, manufacturing, process /quality improvement as well as cost reduction
- Investigate manufacturing process failures, identify root cause and work with other groups as needed to ensure timely resolution
- Create comprehensive Manufacturing Documentation (MPI’s, LHR’s, WI’s)
- Works with Development Engineers to effectively transfer new products to Manufacturing
- Complete design and development projects by training and guiding technicians and assemblers
- Create verification /validation protocols (IQ,OQ,PQ), lead the execution activities, generate relevant data and provide corresponding documentation and reports
- Comply with company’s policies and guidelines regarding design control, validation activities and documentation
Qualifications
- Bachelor's Degree in Mechanical, Chemical, Manufacturing or related engineering fields
- 3-7 years hands-on experience in a manufacturing environment with proven track record of process development /optimization and validation
- Excellent verbal, written, presentation and interpersonal skills
- Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc.
- Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
- Strong analytical and problem-solving skills including but not limited to DOE, and statistical data analysis
- Extensive experience with process capability studies, FMEA, PPK, GR&R, SPC and process development/validation
- Knowledge and experience with plastic injection molding as well as semi-automated and fully automated machines /processes
- Knowledge of material science and polymer chemistry
- Diverse background in process characterization and optimization in a manufacturing environment.
- Hands-on proactive approach to problem solving
- Requires interaction and collaboration with a cross-functional team
Preferred Qualifications
- Experience with Statistical Software tools such as Minitab or JMP
- Knowledge and/or hands-on experience with metrology tools such as CMM, Micro-Vu, SEM, etc.
- Familiarity with cleaning and sterilization processes
- Working knowledge of Solidworks
Travel
- Up to 10%