The RD engineer will be responsible for the development of catheter concept designs, processes and assembly with direct participation in managing costs, issuing quotes to customers, interacting with customers while ensuring full compliance to FDA QSR (21 CFR 820), and applicable ISO 13485 requirements. Perform work in adherence to the CMD Quality Management System (QMS), including development and maintenance of documentation.
SPECIFIC DUTIES & RESPONSIBILITIES:
- Support the quoting process and predict project costs, material lead times, and product delivery schedules during the quoting process
- Develop bills of materials and assembly method, update work instructions and provide any needed training to technicians and assemblers.
- Develop catheters and catheter subassemblies according to customer design, performance, and quality specifications; on time and within budget.
- Work in a cross-functional environment partnering with Operations and Quality departments in order to deliver product that meets customer requirements, on time delivery and quoted price.
- Create new design solutions or leverage existing designs to create cost effective and efficient improvements to assembly challenges.
- Support the development of Specifications for tooling and fixturing according to company quality standards.
- Working knowledge of manufacturing processes related to catheter manufacturing
- Provide technical leadership, root cause analysis, and resolve customer or project related problems; materials, assembly, functional, or processes.
- Capable of developing protocols and executing Qualifications, Validations, Verification and Validation testing, drawings, calculation and Process FMEAs.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirement
EXPERIENCE & EDUCATION REQUIREMENTS:
- 1 to 3 years in a catheter manufacturing environment, with exposure to product design and Fixture design.
- A working Knowledge of minimally invasive Medical Device design, development and manufacturing processes.
- Demonstrated excellent written and oral communication skills.
- High School Diploma or GED required
- Bachelor’s degree in Plastics, Chemical, Biomedical or Mechanical Engineering preferred
- Excellent working knowledge of GD&T and Solidworks
- Experience with design controls, FDA regulation, GMP practices, and QSR requirements
- Paid holidays