What are the responsibilities and job description for the Product Development Engineer position at G&H Orthodontics®?
Company Description: G&H Orthodontics, headquarters in Franklin, IN, is a manufacturer with more than 180 employees, and a worldwide supplier of orthodontic products and supplies. Our global footprint with customers and distributors stretches across more than 100 countries. We are ever-growing and are continually looking to add talented people to our team that are ready to help us grow even more. As a company, we value every employee and customer. We want our customers to feel like they are part of the G&H family.
G&H Orthodontics is always seeking talented and engaged employees with a desire to develop and grow their careers by demonstrating a determined positive attitude with a high drive to perform and succeed. The ideal candidate will bring an "authentic ownership" approach to their work and contributions at G&H.
To learn more about G&H Orthodontic career opportunities, visit Careers | G&H Orthodontics.
Role Description: The Product Development Engineer is a full-time, on-site role based in Franklin, IN. The Product Development Engineer is responsible for advancing the organization’s core products/technologies related to a Class I, II or III medical device. This includes design and development of Orthodontic products, manufacturing validations, and problem solving related to production.
Responsibilities:
- Participate in multi-disciplinary project teams through all phases of project development in accordance with FDA, CSA, EU regulations and G&H’s Product/Quality and Regulatory Development Procedure.
- Leads efforts to identify and document key design requirements that will enable product success in the marketplace.
- Develop tooling
- Design and execute test protocols
- Evaluate material composition and product designs
- Knowledge of regulatory pathways and directives related to medical device (including Class I and II) development and approval for US FDA, Canada and European Union.
- Excellent analytical and problem-solving skills with the ability to interpret data and draw actionable insights.
- Exceptional communication, presentation, and interpersonal skills with the ability to influence and collaborate effectively across all levels of the organization, including vendors.
- Familiarity with Agile development methodologies is a plus.
Required Qualifications:
- Bachelor's degree in mechanical engineering
- 5-7 years' experience working as an engineer for a medical device company, preferrable in orthodontics
- Strong understanding of the orthodontic market, clinical workflows, and the needs of orthodontists
- Proficiency in using CAD software, preferably Solidworks
- Microsoft Office