Argen Corporation currently has an exciting opportunity for a R&D Engineer to join a growing, technology-focused and service-oriented team. If you thrive in a fast- paced and dynamic environment, and want 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 research and development, continually improving on our current products and developing new solutions for the dental industry. Argen provides our global customers with affordable, high-performance products and industry-leading customer service. Argen’s products are FDA regulated and ISO certified.
About the Opportunity
As the R&D Engineer, you will ensure new products meet company targets for quality, performance, regulatory requirements, and cost. Coordinates with other departments to ensure all tasks of each project are completed on time and within budget.
In this role, the successful candidate will:
- Provides expertise in developing engineering solutions to improve the manufacturing of new and existing Argen products.
- Prepares Design History File documentation utilizing cross-functional resources.
- Coordinates internal resources and third parties/vendors for the flawless execution of projects.
- Ensures that all projects are delivered on-time, within scope and within budget.
- Assists in the definition of project scope and objectives, involving all relevant stakeholders and ensuring technical feasibility.
- Ensures resource availability and allocation.
- Develops a detailed project plan to monitor and track progress.
- Manages changes to the project scope, project schedule and project costs using appropriate verification techniques.
- Measures project performance using appropriate tools and techniques.
- Reports and escalates to management as needed.
- Manages the relationship with the client and all stakeholders.
- Performs risk management to minimize project risks.
- Establishes and maintains relationships with third parties/vendors.
- Creates and maintains comprehensive project documentation.
- Tracks project performance, specifically to analyze the successful completion of short and long-term goals.
- Meets budgetary objectives and makes adjustments to project constraints based on financial analysis.
- Develops comprehensive project plans to be shared with clients as well as other staff members.
- Develop spreadsheets, diagrams and process maps to document needs
- Other duties as assigned.
What does it take to be a qualified candidate?
- B.S. in mechanical, electrical, industrial, or other engineering sciences
- Experience with creation of Design History Files; understanding of connection between R&D and commercialization of medical devices within regulatory framework
- 5 years of manufacturing process development, or an equivalent combination of education and experience
- Experience in medical device manufacturing
- Proven working experience in project management; PMP certification is a plus.
- Experience with digital project management tools such as Microsoft Project or Smartsheet.
- Demonstrates ownership of and ability to lead projects with a broad scope and high level of complexity, and able to prioritize and complete work in a timely manner and within budget
- Demonstrates advanced problem solving skills through the use of quality and statistical tools
- Ability to do feasibility studies on advanced processes to estimate product cost and analyze capital equipment, capacity, and capability
- Excellent client-facing and internal communication skills.
- Excellent written and verbal communication skills.
- Strong working knowledge of Microsoft Office.
- 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.
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:
- Medical, dental and vision Plans
- 401k with Employer Match
- Paid Vacation, Holidays 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