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Process / Equipment Validation Engineer (Contract)

a Medical Devices company located in the San Francisco Bay Area, CA

This is a Contract position in Las Vegas, NV posted October 13, 2022.

Process / Equipment Validation Engineer (Contract) RESPONSIBILITIES Taking ownership of key internal and contract manufacturing processes.

Providing strong continuous improvement and leadership competencies to drive quality, delivery, and cost improvements in manufacturing and this will include reviews of current capabilities and establishing new processes.

Partnering with the R&D and Process Development teams to transfer manufacturing processes into production.

Providing engineering support to manufacturing and resolving issues related to process validations Designing, building, or procuring improved fixtures, tooling, or equipment to increase quality, reliability, capacity, and yield Providing floor layouts for areas associated with manufacturing operations Writing test protocols, preforming tests to fully characterize new equipment or processes utilizing DOE methodology or other statistically sound methods, then writing completion reports Performing process capability assessments and establish methods to control process output Creating process validation protocols, conduct process optimization studies, conduct process verifications and validations, and generate verification and validation reports Writing and performing IQ’s, OQ’s and PQ’s when introducing new or changing existing manufacturing equipment Training, developing, and/or providing work direction to operators and technicians Traveling up to 25-30 % travel between company sites and suppliers.

Maintaining trained status for, and comply with, all relevant aspects of the company’s Quality Management System (QMS) to ensure product and support regulatory compliance Understanding and adhering to the company’s Quality and EHS Policy QUALIFICATIONS Minimum 5
– 8 years of relevant experience Subject matter expert (SME) in equipment and process validation.

Medical devices technical transfer experience Experience supporting medical device manufacturing.

Specific experience with process characterization, equipment IQ/OQ, process OQ, PQ and PPQ.

Specific experience with Test method Validation Extensive experience with root cause analysis and problem solving for both technical and process issues.

Preferred experience with Lean and Six Sigma tools.

Experience working in a structured design process such as ISO9000 or FDA QSR, knowledge of regulatory approval process and requirements.

Working knowledge of design control and cGMP requirements for medical device manufacturing per FDA QSR and ISO13485-2003 or ISO9001and EN46001.

Basic working knowledge of CAD software (i.e.

Solid works, etc.).

Excellent computer skills with specific skills in Microsoft Office and proficient in SolidWorks.

Laser equipment and laser processing experience is a PLUS EDUCATION B.S.

in Industrial, Mechanical, or Electrical Engineering or related engineering discipline

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