Company Overview

Young Innovations is a growing mid-sized manufacturer and marketer of high quality dental equipment and supplies. We have an outstanding reputation for quality and customer service. Our company has a broad portfolio of market leading products across a variety of categories.

Position Overview

We are looking for a broadly experienced Product Development Chemical Engineer who thrives in a dynamic and fast-paced role. The Product Development Chemical Engineer is responsible for supporting new product development of Young Dental's Prophy Paste, Fluoride Varnish and other chemical products.

ESSENTIAL DUTIES: 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.

Specific Processes:

• Assist in the Product Development Process to help increase pace of development for Class I and II medical devices or drugs.
• Provide project leadership to multiple projects, simultaneously ensuring timelines and budgets are appropriately managed and goals are achieved.
• Formulate prototypes, lab batches and prepare sample requests for internal or external stakeholders.
• Complete evaluations as outlined in engineering studies, protocols, product / process validations, complaint evaluations, etc.
• Assist in developing/performing test method including validation protocol/reports for active pharmaceutical ingredients and/or finished product specifications.
• Clearly and effectively write protocols, reports, and presentations using MS Office products.
• Assist in gathering raw materials, pre-weigh and scale up for pilot batches and packaging with supervision.

• Use standard statistical methods to determine and interpret results using Excel, Minitab, or any other statistical software.
• Assist in managing R&D stability by preparing stability samples, writing stability protocols, create stability specifications, perform physical and analytical testing, entering data/result in software and write reports.
• Assist in writing/reviewing standard operating procedures, batch records, packaging records, bill of materials, routings and product specifications for all chemical products.
• Troubleshoot formula issues related to stability, and work closely with production to evaluate any issues related to scale-up or manufacturing transfer.
• Complete risk analysis for products or processes with guidance from other department members.
• Product or Process cost estimation for line extensions or small scale projects - Create or interpret routing and bill of materials using IFS or any other ERP software.

MINIMUM QUALIFICATIONS:

• B.S. in Chemistry, Biochemistry, Chemical Engineering or Biomedical Engineering
• 2-4 Years of experience in medical device, pharmaceutical, or food product development. Applicants with significant internships or a full Co-op term in an applicable field would qualify.

Knowledge, Abilities and Skills

• Demonstrated ability to manage multiple projects
• Ability to work in groups
• Strong verbal and written communication skills
• Strong chemical background and problem solving skills
• Intermediate knowledge of Laboratory Equipment and Procedures Testing Instrumentation –mixer, homogenizer, stability chambers, pH determination, fluoride content determination, viscometer, specific gravity and microbiological tests.
• Intermediate knowledge of MS Word and Excel
• Basic knowledge of statistics
• Project Management - MS Project or SmartSheets preferred
• Design of Experiments
• Basic knowledge Product or Process Validations
• Basic knowledge of cGMP and regulatory requirements (medical device and/or drugs)
• Basic knowledge of dental products or medical devices
• Follow all safety and good housekeeping procedures to maintain safe working environment.

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 trade shows, vendors, or customers to provide technical assistance when needed.

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