Manufacturing Engineer II

Argen Corporation • San Diego, CA

18h

About The Position

Argen Corporation currently has an exciting opportunity for a Manufacturing Engineer II to join a growing, technology-focused and service-oriented team. Argen is a family-owned and privately held company based in San Diego, CA with a state-of-the-art manufacturing center that provides high quality dental solutions to dental labs of all sizes. Founded as a precious metals company in South Africa, Argen has evolved into a dynamic, technology-based manufacturing organization focused on three key business segments, including dental alloys, zirconia, and digital dentistry solutions. Argen continues to invest in innovative product improvement initiatives through its Quality Management System to provide our global customers with affordable, high-performance products and industry-leading excellent service. Argen’s products are FDA regulated and ISO certified.

Requirements

• B.S. degree or equivalent in engineering or related field.
• 3 years of related experience.
• Strong communication skills.
• Experience preparing and reading technical documentation.
• Working knowledge of standard machine shop equipment and process.
• Knowledge of medical and technical development.
• Ability to use MS Office and other manufacturing systems.
• Knowledge of Process Validations in medical device manufacturing environment.
• Troubleshooting and problem solving skills.
• Minimum 2 years’ experience in CAD tooling/fixture design (SolidWorks preferred).

Nice To Haves

• 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.

Responsibilities

• Responsible for overseeing and reviewing process development, equipment/tooling design, process characterization, process validation, inspection and test development, risk documentation, statistical analysis, production documentation.
• Drive product product/process/yield improvement activities in partnership with other functional areas such as Manufacturing, Research & Development, Facilities, and Quality departments.
• Prepares and/or reviews all protocols and reports involving validation tasks.
• Resolve manufacturing issues that require an engineering solution
• Implements design features and design changes into production by developing new engineering solution and updating manufacturing documentation
• Executes design verifications and process validations including writing protocols and test reports
• Contributes to cross functional teams for completing activities such as Failure Mode & Effects Analysis (FMEA), process control, or other activities as required
• Completes documentation for all projects to ensure FDA and global compliance with regulatory requirements
• Provides engineering support for manufacturing and quality troubleshooting
• Provides technical expertise and guidance for the preparation and execution of validation protocols and reports.
• Reviews and investigates anomalies.
• Gathers data and performs analysis.
• Resolves and consults on applicable validation compliance and manufacturing process issues.
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
• Implement new equipment (calibration/set up) and perform training to operation team
• Reviews and develops manufacturing documents (WI, SOP, Forms, etc.).
• Other duties as assigned.

Benefits

• Health/Dental/Vision Plans
• 401k with Employer Match
• Paid Vacation, Holiday and Sick Time
• Employee Events
• Wellness Programs
• Discounts for home, travel, entertainment, relaxation that includes Mobile phone service, Technology, Airline and Hotel, Theater/Theme Park tickets, Restaurants and so much more!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level