Designs mechanical and electromechanical medical laser products and systems by developing and testing specifications. Provides technical leadership and work with a cross-functional matrix team of engineers and scientists in designing components, assemblies, and processes used in the medical device industry.
Core Job Duties:
• Designs Mechanical of the next generation laser photo-coagulator and other eye care products.
• Provides technical leadership to development teams in mechanical, opto-mechanical and controls design.
• Chooses new technologies and materials and identify and interact with strategic vendors to obtain engineering materials, processes, and equipment
• Interfaces with Program Manager to ensure customer requirements are understood and transferred correctly to engineering specifications.
• Works with cross functional teams to identify, plan and execute tasks to bring products from concept through to market release.
• Provides technical guidance to teams to develop and improve manufacturing processes to pilot production level.
• Assists in compliance and environmental testing.
Education & Experience:
• Six (6) years, minimum, experience as a mechanical engineer in the medical device industry.
• Bachelor’s degree in Mechanical Engineering or equivalent experience, Master’s degree preferred.
• Proven ability to solve problems independently and manage the workload of multiple projects and tasks
• Extensive knowledge and proven track record of complex mechanical designs.
• Experience in 3-D solid modeling: SolidWorks, Pro/E. Direct experience with SolidWorks preferred.
• Experience with rapid prototyping.
• Expert knowledge of engineering materials for machining and design for injection molding.
• Hands-on building and familiarity with general prototype principles and processes
• Experience in conceptualizing innovative and creative designs using strong analytical and problem solving skills.
Knowledge, Skills and Abilities:
• Ability to effectively and clearly communicate technical concepts, ideas and knowledge to other individuals and teams.
• Working knowledge of ISO requirements, FDA regulations including Quality System Regulations, medical device design control, CE marking and product safety regulatory standards and manufacturing processes.
• Proficient SolidWorks and/or Pro/Engineer 3D modeling capabilities
• MS Office Suite