Manufacturing Engineer II
Location: San Diego
Posted on: June 13, 2021
Manufacturing Engineer II
Argen Corporation currently has an exciting opportunity for a
Manufacturing Engineer II to join a growing, technology-focused and
service-oriented team. Do you thrive in a fast- paced and dynamic
environment? If you would like to be a part of an organization with
an unwavering commitment to quality dental solutions, then explore
our career opportunities and get to know Argen.
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
In this role, the successful candidate will be:
- 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
- Implements design features and design changes into production
by developing new engineering solution and updating manufacturing
- 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
- 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
- Implement new equipment (calibration/set up) and perform
training to operation team
- Reviews and develops manufacturing documents (WI, SOP, Forms,
- Other duties as assigned.
What does it take to be successful?
- 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
- Knowledge of medical and technical development.
- Ability to use MS Office and other manufacturing systems.
- Knowledge of Process Validations in medical device
- 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
- Troubleshooting and problem solving skills.
- Minimum 2 years' experience in CAD tooling/fixture design
Our Awesome Benefits!
Working for a growing innovative company like Argen means
exciting opportunities for training and learning, career
development and advancement from only the best in the dental
industry. With all that hard work, Argen is committed to ensuring
the welfare of its employees and provides an amazing benefit
package that includes:
- 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!
EOE/M/F/Vet/Disabled VEVRAA Federal Contractor
Keywords: Argen, San Diego , Manufacturing Engineer II, Other , San Diego, California
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