Product Development Engineer

Company Info
Apple & Associates
Chapin, SC, United States

Phone: 330-265-7231
Web Site:

Company Profile


Product Development Engineer


Cleveland, OH 


70000 - 110000

Job ID:


Job Description:

Our client, a small and fast-growing $30M Medical Device Company in optical and hand-held technology products sold to primary care, hospitals and retail pharmacies is searching for a Product Development Engineer - Mechanical or Biomedical Engineer.  The Product Development Engineer role presents an exciting opportunity to work with a talented and motivated team (6-10 on the team) to develop and bring to market novel devices and systems for ophthalmology applications.  You should be a highly motivated, talented, and intelligent individual who has experience designing and developing components to sub or final assemblies, working with simulation and hands-on with Solidworks to design components for machining and injection molded applications. This engineer will be designing opto-mechanical components and sub-systems, but does not have to have experience in opto-mechanical products.  


Product Development Engineer - Mechanical Engineer Essential Functions/Skills:

  • Lead the mechanical design of new ophthalmic diagnostic and treatment products including fundus imaging systems, surgical devices, and other non-invasive eye examination instruments.
  • Conceptualize, design, and develop mechanical components and sub-assemblies that interface with optical and electrical systems.
  • Design space efficient components working closely with optical and electrical engineers to integrate designs in compact usable systems.
  • Configuration of ground-up product designs and systems layouts using Solidworks 3D modeling software.
  • Perform mechanical engineering analyses including static and dynamic loading case, impact scenarios, thermal loading, etc, utilizing computational modeling to enhance system analysis.
  • Perform comprehensive component and system level tolerance analyses.
  • Develop test and inspection methods for evaluating components and sub-systems.
  • Support design control activities including preparation of Design Input Requirement, design-process-user FMEAs, and design verification and validation documents.
  • Identify and define critical attributes of mechanical components to inform required component inspections or in-process testing.
  • Prepare technical documentation including presentations, engineering analysis reports, and technical work instructions.
  • Lead design control efforts as required by regulating bodies for the development and commercialization of Class I and Class II medical devices.
  • Interface with optometrists and ophthalmologist as part of the new product and evaluation process.
  • Provide technical support to customer service, quality regulatory teams including root cause investigations of product failures or non-conformances.