|Title:||Mechanical Product Engineer|
|Job Location:||Grafton, WI|
Microbrush International develops, produces, and markets innovative disposable applicators designed for the placement of controlled amounts of materials in hard-to-reach areas. Microbrush is a wholly owned subsidiary of Young Innovations, Inc. Young Innovations is a manufacturer and marketer of high quality dental equipment.
We are a growing manufacturing organization with a focus on quality and constant improvement seeking a Mechanical Product Engineer to join our team. The Mechanical Product Engineer will be responsible for supporting Young Innovations’ mechanical orientated products. These include, but are not limited to, micro-applicators, flow-through brushes, moisture control products and others.
- Assist and lead the product development process for Class I and Class II medical devices
- 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.
- 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.
- B.S. in Mechanical or Biomedical Engineering
- 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 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 medical device Design Control
- 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
- Ability to travel 10%
Young Innovations/Microbrush International are an Equal Opportunity Employer and E-Verify participating employer