The Best Hearing Requires a Lens
Earlens is a privately held medical technology company that has developed the Earlens® hearing solution. This revolutionary, nonsurgical treatment for hearing loss uses a small lens to vibrate the eardrum, replicating the natural hearing process. With more than 185 US and international patents, Earlens was named to Time Magazine’s list of the top 100 inventions of 2020. Earlens is exclusively available from a growing network of highly trained Ear, Nose & Throat physicians and audiologists who are supported by dedicated concierge customer service.
As a key member of a medical device product development team, you will lead activities associated with product development/manufacturing transfer. This individual will be responsible for leading the Digital Manufacturing team in areas such as: manufacturability, cost reduction, process control/characterization, documentation, validation, and production support. Additionally, you will serve as a technical interface with key suppliers.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Will be responsible for the design of custom eartips and associated products through the use of 3D scanning, design and 3D printing
• Establishment of process flow and production line layouts
• Process development/statistical analysis
• Perform process validations (IQ/OQ/PQ)
• Write protocols and test reports
• Develop the organization’s core competency by selecting equipment, software and conducting training courses
• Ability to work in a fast-paced dynamic environment
• Transfer new products from R&D to Manufacturing through the design control process
• Hands-on individual with demonstrated experience in the design and development of custom eartips through the use of additive manufacturing
• Ability to solve problems using structured methods.
• Have a firm understanding and demonstrated experience performing medical device process validations.
• Firm understanding of manufacturing techniques with the ability to quantify line capacities and to develop high volume manufacturing scale-ups.
• Statistical Process Control, Green Belt experience preferred
• Experience utilizing 3D printing, Geomagic Studio, Rhinos, 3Shape and Solidworks to produce custom hearing components preferred
EDUCATION and/or EXPERIENCE:
• BS Degree in Engineering or equivalent
• Manufacturing experience with custom products preferably RIC or CIC eartips
• Experience in experimental techniques, statistical analysis & engineering investigation techniques (six sigma green belt preferred)
• Five (5) years experience in leading projects
• 5-10 years experience in medical device manufacturing experience
To apply for this job please visit www.earlens.com.