Manufacturing Process Engineer

Valid8 Financial, Inc.; San Jose (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

An innovative company in the manufacturing sector is seeking a skilled engineer to enhance production processes. This role involves evaluating existing workflows, implementing improvements, and ensuring compliance with industry standards. The ideal candidate will possess a Bachelor's degree in engineering and have significant experience in process optimization and validation. You will collaborate with cross-functional teams, engage in problem-solving, and contribute to the development of new products. Join a dynamic environment where your contributions will directly impact productivity and quality in manufacturing.

Qualifications

• 3-7 years of hands-on experience in manufacturing with process optimization.
• Strong analytical skills including DOE and statistical data analysis.
• Knowledge of FDA regulations and ISO standards.

Responsibilities

• Evaluate and improve manufacturing processes to enhance productivity and quality.
• Develop standards to reduce variability in manufacturing processes.
• Investigate process failures and collaborate for timely resolutions.

Skills

Process Development

Statistical Data Analysis

Problem-Solving

Manufacturing Process Optimization

FDA Regulations Knowledge

ISO Standards Knowledge

Communication Skills

Analytical Skills

Plastic Injection Molding

Education

Bachelor's Degree in Mechanical Engineering

Bachelor's Degree in Chemical Engineering

Bachelor's Degree in Manufacturing Engineering

Tools

Minitab

JMP

CMM

Micro-Vu

SEM

Job 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
• 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