Product Development Engineer I
Tympanogen is a medical device company based in Richmond, VA with a mission to improve healthcare by simplifying surgical procedures. We develop gel-based medical devices for the ear, nose, and throat industry and transform eardrum surgery into an office-based procedure. We are hiring a Product Development Engineer I to support our team during development of our ENT devices. This position works closely with multifunctional team members to guide product integration with research, development, and regulatory initiatives. These vital efforts drive the successful implementation of design concepts and device validation to introduce Tympanogen’s products to market.
The duties for the Product Development Engineer I would include:
- Interact with potential product users to gain feedback and guide product development;
- Work with contract manufacturers through design and output phases of the product’s components;
- Assist with documentation and monitoring the progress of the product development for company visualization;
- Integrate product verification and validation needs into quality management system alongside internal personnel and external vendors;
- Provide and assist with interpretation of verification and validation reports for regulatory documentation;
- Establish creative solutions and roadmaps for continuous product improvement through collaboration with internal and external partners;
- Facilitate site process reviews and participate in process risk and opportunities assessments;
- Assist with future product design, prototyping, and identifying potential partners.
Experience and Qualifications
- Bachelor’s degree in mechanical engineering, biomedical engineering, biology, or related field;
- A basic knowledge of Microsoft-based computer programs including some scientific, graphic, and statistical software is required.
- MS degree in biomedical engineering or related field;
- Experience in the medical device industry;
- Experience/familiarity with U.S. FDA, GMP, and ISO requirements for the design, validation, manufacturing processes, secondary operations, risk analysis, and assembly of medical components and devices.