Topcon Healthcare Solutions (THS), headquartered in Oakland, NJ, is a leading software engineering company of the eye care industry. THS is responsible for R&D, engineering, marketing, sales, and support of software solutions to the global market.
Topcon's mission is to make the impossible possible, by constantly innovating optical, imaging, and measurement technologies and developing new and advanced image management and networking solutions. Our goal is simple: to provide the ophthalmic medical community with the most innovative and indispensable software solutions so that doctors and researchers can better serve patients, ultimately improving outcomes in eye and vision care. THS is newly established in 2017 to provide the most advanced software solutions to the global market. We focus on IoT, Cloud and AI technologies to enable “Healthcare through the eye”.
Topcon Healthcare Solutions is a wholly owned subsidiary of Topcon Corporation of Tokyo, Japan.
Job Purpose: Perform mechanical and opto-mechanical design for the next generation medical device products in eye care. Develop engineering requirements and specifications and conduct design verification testing. Provide technical leadership and work with cross-functional team of engineers and scientists in designing components, assemblies, and processes used in the medical device industry.
Core Job Duties:
• Design, develop and test mechanical and optomechanical systems for class II medical devices
• Monitor and manage the efforts of third-party vendors and suppliers, define product or component specifications, qualification efforts, and development schedules
• Perform risk analysis and conduct engineering testing and activities to reduce technical risk
• Hands-on work with prototype design, assembly and process development
• Write and execute testing procedures, conduct design verification testing, and compile test reports
• Develop test plans to meet product MTBF, product expected life and reliability goals.
• Construct bill of materials, and ensure smooth design transition to manufacturing
• Design and develop jigs and test fixtures for device assembly and fabrication
• Support product compliance and environmental testing as well as industrial design efforts with outside resources
• Design, test and document in accordance with medical design regulations. Support regulatory submissions.
Education & Experience:
• Six (6) years, minimum, experience as a opto-mechanical engineer in the medical device industry.
• Bachelor’s degree in Mechanical Engineering or equivalent experience, Master’s degree preferred.
• Proficient with SolidWorks and/or Pro/Engineer 3D modeling capabilities, or other 2D & 3D CAD packages
• Thorough working knowledge of opto-mechanical engineering fundamentals. Familiarity with Zemax, Code V, or other optical design packages.
• Experience with rapid prototyping.
• 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:
• Extensive knowledge and proven track record of complex mechanical designs.
• Proven ability to solve problems independently and manage the workload of multiple projects and tasks
• 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.
• Ability to work with small objects and/or component parts , operate small hand tools, small power tools and common laboratory test/inspection equipment
• Working knowledge of machine shop tools and equipment is preferred