KORU Medical Systems is a leading developer and manufacturer of medical devices that help patients have the best possible experience subcutaneously infusing biologic medications at home. KORU’s primary line is the FREEDOM Syringe Infusion System, including the FREEDOM60® and FreedomEdge® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HIgH-Flo Subcutaneous Safety Needle Sets™. The Company maintains its corporate headquarters and manufacturing facility in Chester, New York. For more information about the Company, please visit www.korumedical.com.
The Senior Development Engineer will use expert technical skills to conceive, plan and lead R&D product development activities to achieve project goals. You will leverage understanding of advance engineering principals, advanced engineering methods, data, and judgement to influence the course of product development activities.
Essential Job Functions:
- Applying technical expertise in mechanisms, fluidics, and electronics to lead efforts in test method development, implementation, and validation for medical device/systems.
- Responsible for designing and developing a product/product family. Able to prepare a set of drawings for a complex system, analyzing tolerances during the process.
- Leading efforts in creating and developing fixtures and building test stations for characterization, experimenting, and testing medical device/systems
- Ensures production procedures efficiently utilize materials and personnel.
- Tests finished product for quality purposes and recommends changes to product specifications, as necessary.
- Assessing design feasibility and testing product functionality and/or confirm product capabilities
- Participating in the evaluation and assessment of competitive products, processes, and/or new trends
- Developing system modules to facilitate decisions concerning system architecture, system requirements, design tolerance allocation and risk management
- Bachelor’s Degree in engineering, required.
- Master’s degree in engineering, strongly preferred
- 8+ years relevant experience as a product development engineer
- 3 years’ experience in plastic injection molding part and process design
- Medical Device experience required
- Strong experience with design transfers functions, system modeling and simulation, and risk management.
- Experience with ISO requirements and GMP guidelines, FDA regulations, design control.
- Design for Six Sigma, preferred; Six Sigma certification, preferred
- Proven ability to deliver results under tight deadlines
- Knowledge in GD&T and good drawing formatting skills
- Excellent analytical, problem-solving, and critical thinking skills
- Ability to lead, influence and communicate with diverse cross-functional teams
- Excellent writing, presentation skills; strength in Excel and PowerPoint
Please fill out the form below to submit your application.