Manufacturing Engineer I

at  Argen Corporation

About the Opportunity
The Manufacturing Engineer I contributes to sustaining efforts in a low-to-medium volume medical device manufacturing environment. Responsible for troubleshooting issues, defining and performing validation on equipment and processes, improving equipment uptime and reliability and all required and accompanying documentation.

ABOUT US

At Argen, we’re in the business of creating healthy, confident smiles one case at a time. Argen is a global leader in dental manufacturing with headquarters in San Diego, CA, subsidiaries in Canada, Germany, UK, and China, and sales in 105 countries worldwide. We have a team of 400 Awesome team members. Founded more than 50 years ago as a precious metals company in South Africa, Argen has grown to become the largest dental zirconia manufacturer in North America, largest dental alloy provider worldwide, and leader in digital dentistry solutions with a product offering that span fixed, removable, ortho, implants, and equipment. Argen embodies a culture of innovation, continuous improvement, and LEAN practices in support of our mission to help our dental laboratory customers succeed

• Maintains operational readiness of manufacturing equipment and/or works with manufacturing team when manufacturing issues arise.
• Develops and/or optimizes manufacturing processes in an FDA regulated quality system.
• Utilizes lean manufacturing practices to improve production output.
• Evaluates manufacturing processes and equipment to identify areas of improvement.
• Ensures all projects and processes are in compliance with FDA, Current Good Manufacturing Practices (cGMP), Quality Management System (QMS), and other applicable requirements.
• Writes, edits, reviews Installation Qualification, Operational Qualification, Performance Qualification, and/or Process Validation documentation (IQ/OQ/PQ/PV protocols), Standard Operating Procedures (SOP), technical reports, engineering test protocols, and reports for new/existing products, processes, and equipment.
• Designs and executes controlled experiments (including DOE’s) to troubleshoot production line issues, address yield and quality issues, and drive implementation of solutions to meet production goals.
• Assists in identification and implementation of advanced manufacturing technologies and make recommendations for process requirements of new or existing product lines.
• Assists in the review and evaluation of capacity models and anticipate when new equipment or additional headcount will be required.
• Evaluates technical problems and drives down to root causes to implement sustainable resolutions.
• Provides training to manufacturing personnel on operating processes and equipment.

What does it take to be successful?

• BS Degree in Engineering
• Strong SolidWorks experience and fixture/tooling design is a plus.
• Experience in a medical device and/or biopharma manufacturing environment preferred.
• 0-3 years of experience in an engineering function in a cGMP/FDA/ISO manufacturing environment specifically related to processes and equipment.
• Direct experience with Equipment Qualification (IQ/OQ/PQ) and/or Process Development and Validation in an FDA Class II/III industry preferred.
• Proven self-starter with the ability to identify areas of improvement and/or need and act accordingly to produce objective results.
• Proven problem solver/learner who thrives in fast past environment and solving puzzles.
• Excellent written and verbal communication skills.
• Organization and time management skills and ability to pay close attention to detail.
• Able to work in cross-functional teams efficiently and effectively.
• Flexibility to change direction frequently and handle a fast-growing pace environment.
• Ability to focus on directed priorities, tasks, and projects.
• Ability to learn technical concepts by reading work instructions and standard operating procedures and completing on-the-job training.
• Knowledge of cGMP regulations ISO 13485, 21CFR Part 820, CMDR SOR/98-282, 93/42/EEC, RDC 16 2013, MHLW MO 169 and TG(MD)R Sch3 preferred.