Company Overview
Young Innovations is a manufacturer and marketer of high-quality dental equipment and supplies. With an outstanding reputation for quality, our company has a broad portfolio of market-leading products across a variety of categories.  Preat Corporation is a subsidiary of Young Innovations and is an aggressive, fast-growing, successful Dental Prosthetic Manufacturer and Supplier. 

Role Overview
We are looking for a dynamic individual to join our team at Preat Corporation at our Santa Maria, CA facility. Under the supervision of the Director of Product Development, this position will serve as an experienced resource to support new product development for Young Innovations’ Implant Accessory business. Responsibilities will include preparing design control documentation and performing requisite testing for both new products and retroactive designs as well as general support for mechanical design projects. Projects can include but are not limited to; performing in-house testing or managing outside test labs, producing design control documents for existing products or new line extensions, supporting design changes, and root cause investigations. Products include, but are not limited to implant components, attachments, and related supplies or tools.

Responsibilities

• Serve as a technical and project resource to drive project completion, innovation and enhancements of existing products to continuously meet the needs (both known and unknown) of the customer.
• Assist and lead the design control process for Class I and Class II medical devices. This may include design file remediation of existing products, line extensions, design changes, and new product development.
• Serve as the internal “subject matter expert” for mechanical design principles and test methods.
• Provide project leadership to multiple projects, simultaneously ensuring timelines and budgets are appropriately managed and goals are achieved.
• Write and execute protocols, reports, inspection guidance, engineering studies, test methods, complaint analyses (as determined by QA), MRB analyses (as determined by ops), and ERP documentation for new products.
• Complete risk analysis for products or processes with guidance from other department members.
• Complete 3D modeling or drawings for product line extensions or prototypes using SolidWorks (preferred) or any other modeling software.
• Product or Process cost estimation for projects - Create or interpret routing and bill of materials using IFS or any other ERP software.
• Use standard statistical methods to determine and interpret results using Excel, Minitab, or any other statistical software.
• Organize and accelerate the product development process through rapid prototyping, specifically 3D printing or machining of prototypes.
• Manage responses to Quality, Regulatory, Engineering, Operations, Sales and Marketing requests for samples, necessary specifications, quality standards, test methods, materials information, processing limitations, etc. as deemed necessary.

Qualifications

• B.S. in Mechanical or Biomedical Engineering
• Experience working within medical device Design Control processes
• 5+ Years of experience in medical device, pharmaceutical, or food product development.
• Proven ability to lead technical projects is preferred.
• Must be results-oriented and capable of managing multiple tasks in a dynamic environment.
• Must be a team player with strong interpersonal skills who can organize work tasks to effectively complete projects and create win-win situations when possible.
• Must also work independently and take a hands-on approach to the work when necessary.
• Excellent written and oral communication skills, and capable of interacting with different functional groups within the business.
• Advanced knowledge of SolidWorks
• Intermediate / Advanced knowledge of Product or Process Validations
• Intermediate / Advanced knowledge of Risk Analyses
• Intermediate knowledge of Design of Experiments
• Intermediate knowledge of Rapid Prototyping Techniques (3D printing, machining)
• Intermediate knowledge of Injection Molding Part or Fixture design
• Intermediate knowledge of statistics
• Basic / Intermediate knowledge of Project Management concepts and software - MS Project or SmartSheets preferred
• Basic knowledge of dental products or medical devices

Physical Requirements

• Office environment, with Sitting and Standing for long periods of time.
• Occasional exposure to manufacturing plant environment, with some abnormal variations in temperature, unavoidable fumes, noise, dust and atmospheric conditions.
• Periodic lifting or moving objects 40 lbs. or less.
• Ability to travel 10% or less. Visit sister facilities, trade shows, vendors, or customers to provide technical assistance when needed.

Preat/Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer