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Manufacturing Process Engineer

Company: InCube Labs
Location: San Jose
Posted on: November 21, 2020

Job Description:

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:

Responsibilities

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.

Completes 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

Enteric coating

Travel

Up to 10%

PM20

PI126108131

Keywords: InCube Labs, San Jose , Manufacturing Process Engineer, Other , San Jose, California

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