Senior Manufacturing Process Engineer

InSound Medical, Inc., a developer and manufacturer of the next-generation hearing solution, is seeking a Senior Manufacturing Process Engineer to work on our team.  Our company, founded by ENT physicians, hearing specialists, and engineers from the University of California, San Francisco and Silicon Valley, have developed the first and only 100% invisible extended wear hearing solution.

 

The primary focus of this position will be to develop, support and improve all manufacturing processes for our manufacturing line, manufacturing methods, systems, and processes used in the production of our InSound hearing aid.  Specific responsibilities include developing and implementing process and product improvements, process qualifications and process validation.  Other duties include: 

·   Create and evolve company-critical production equipment and methods from concept to initial pilot runs to high yield, high volume production volumes, particularly in the areas of foam component fabrication, battery assembly, and electronic system assembly.

·       Scale methods from initial prototypes to high volume production volumes, including areas such as electronic component integration and injection molding

·      Work closely with vendors and subcontractors

·       Perform analytical calculations

·      Develop test methods, protocols, fixtures and equipment, reports and conclusions to evaluate components and finished medical devices

·        Develop process control experiments leading to process experiments

·       Work closely with QA to develop standards, perform qualification testing, perform failure analysis, and to continuously improve the company’s products and processes.

 

Education and Experience:  BS in engineering, prefer MS degree; History of designing manufacturing equipment, plant layout and product packaging configurations; Excellent writing and reporting skills to generate manufacturing procedures and reports;  an in-depth understanding of GMPs and QSR; familiar with Design of Experiments (DOE) and statistical analysis, mechanical aptitude for process analysis and optimization; project planning experience; experience in SolidWorks.  Hearing aid design experience a plus.

 

InSound Medical is located in Newark, California and is an equal opportunity employer.  We offer excellent company benefits including medical, dental, vision, life, LTD, Flexible Spending Accounts, 401(k) plan, and three weeks paid time off per year.  Our corporate culture is strong and we place our customers at the center of what we do.  For more information about InSound, please go to our website at www.insoundmedical.com.  

 

If you think you are the right person for this role, please email your resume to careers@insoundmedical.com or fax to (510) 456-2827.