Job Summary:

This position will responsible for the selection and development of metallic and nonmetallic materials and process technologies in support of the design and manufacture of orthodontic products; scope of nonmetallic materials will include ceramics, plastics, composites, and elastomers, along with organic and inorganic coatings.

Duties & Responsibilities:

• Applies sound materials and materials processing principles in the selection and specification of materials and component development with regard to strength, reliability, corrosion resistance, manufacturability, and biocompatibility for design optimization.
• Works with cross functional teams including manufacturing, quality, regulatory, and supply chain personnel to resolve design, production, quality or regulatory issues; uses appropriate techniques to solve problems and develop efficient and sustainable manufacturing practices.
• Performs complex assignments often requiring development of new or improved materials/processes/fabrication and assembly techniques, and associated data-sets. Conducts process capability studies and develops process controls as needed.
• Contributes to appropriate risk management activities related to the design and development of medical devices in compliance with FDA/CE/Health Canada and all other global regulatory agency requirements.
• Develops project-related data for new or improved materials/processes/fabrication and assembly techniques with coordinated regulatory approval.
• Assesses industry trends and opportunities for new technologies and implements investigative research and development initiatives to advance competitive designs.
• Keeps abreast of emerging materials and coatings technologies applicable to orthodontic products; where appropriate, works with academic or other research institutions to advance the development of novel materials for use in orthodontic products.
• Appropriately treats, evaluates, and interprets data generated in manufacturing processes (such as process control and loss data) or from experimental results through statistical analysis, data presentation, etc., for the purposes of understanding trends, making predictions, and communicating effectively in the workplace.
• Reviews project-related documentation, including supplier material and process specifications, design data and qualification/substantiation data to ensure its accuracy.
• Participates in professional organizations to maintain current knowledge of technical innovations.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors; has working knowledge of appropriate analysis techniques and instrumentation to obtain necessary information.
• Assists with supplier qualification and product quality assurance.
• Perform additional responsibilities as requested to achieve business objectives.

Qualifications:

• BS Materials Engineering or equivalent required.
• 3 - 5 years’ experience in materials and process engineering desired.
• Strong ability to communicate both verbally and in writing is required.
• Demonstrated expertise in advanced materials, materials processing, and materials performance is desired.
• Experience with manufacturing process control desired.
• Demonstrated data-driven problem solving ability required.
• Strong understanding of materials analysis techniques (such as macro- and microstructural evaluation, hardness testing, metallurgical sample preparation, SEM/EDS, etc.), DOE, SPC, and industrial statistics desired.
• Demonstrated ability to manage own projects with a high energy level
• Basic understanding of regulatory requirements for medical device design control and manufacturing strongly desired.
• Knowledge of Lean Concepts and Six Sigma desired.

Competitive Pay & Benefits:

• Paid vacation and 11 paid holidays
• Medical, dental, life, and disability insurance
• HSA and FSA accounts
• 401k with company matching and profit sharing
• Tuition reimbursement