Our client is seeking an experienced project engineer to support and enhance their manufacturing operations for medical disposable products. This role involves regular support of manufacturing activities, including IQ/OQ/PQ processes, risk management documentation, process development, training, and LEAN implementation.
Job Duties & Responsibilities
Define and implement verification and validation activities.
Ensure adherence to project schedules.
Facilitate project planning and reviews.
Conduct risk analysis and implement mitigation solutions.
Design manufacturing jigs, fixtures, and equipment.
Develop and write work instructions.
Create internal label specifications.
Process document change orders (DCOs) promptly and accurately.
Support manufacturing to meet quality standards, cost targets, and production schedules.
Develop safe, mistake-proof processes with clear instructions using design for manufacturing principles.
Provide complete documentation to support purchasing activities, including sourcing and qualifying vendors.
Perform failure analysis and implement corrective and preventive actions to support quality.
Provide cost and expense information to accounting as required.
Perform other duties as assigned by the manager.
Education & Experience
Bachelor's Degree in Manufacturing or Process Engineering, or equivalent work experience.
Experience in the medical device industry.
Proficiency in software applications such as Microsoft Word, Excel, PowerPoint, Project, SolidWorks, and Minitab.
Knowledge of manufacturing processes, including Lean Manufacturing, packaging and labeling, clean room, and sterilization processes.
Experience with semi-automated equipment implementation, including working with external equipment manufacturers, design inputs, and validations (FAT, SAT, IQ, OQ, PQ).
Knowledge of materials selection, including physical properties and biocompatibility (ISO 10993).
Understanding of product design, design for manufacturing, and drafting standards.
Familiarity with FDA and ISO design control regulations.
Preferred Skills & Abilities
Excellent verbal and written communication skills.
Strong organizational skills.
Mechanical aptitude with the ability to install, assemble, repair, and maintain production equipment.
Working Conditions & Physical Demands
Regularly required to sit, stand, bend, reach, and move about the facility.
Perform most manufacturing operations on an intermittent basis.
Ability to climb ladders and lift up to 45 pounds.
Travel via personal vehicle for vendor and customer visits; air travel as required, including international travel (passport required).
Must meet all requirements for cleanroom access.
Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Contact: kgregor@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
