About the role
Responsibilities
The **Senior R &D Engineer **is responsible for developing novel catheter prototypes, supporting animal studies, presenting new concepts, and maintaining detailed drawings. This includes writing or verifying specifications, developing testing and product processes, and designing fixtures, to ensure the concepts and/or prototypes meet requirements.
What You Will Do
- Under minimal supervision; research, design, develop, modify, and verify components/modules for medical device product development.
- Translate and/or define design inputs to engineering specifications and produce sub-system level designs. Follow fundamental industry standards, design requirements, and test strategies which apply to regulatory requirements.
- Develop and prototype new catheter-based concepts, subassemblies, and accessories.
- Demonstrate advanced understanding of customer needs and design inputs, and ensure product meets clinical procedural needs.
- Independently create or refine engineering documentation and follow R&D procedures like design controls and risk management, per the Quality Management System.
- Collaborate with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing, and Project Management to ensure project success.
- Maintain current knowledge of competitive technologies in addition to new medical, technical, and biomedical developments related to products and therapies.
- Supervises and mentor technicians, specialists, associate engineers, and engineers.
What You Need (Required Qualifications)
- Bachelor of Science Degree in Engineering; Mechanical Engineering or Biomedical plus 2+ years of relevant work experience.
Preferred Qualifications
- Master of Science Degree in Engineering, Mechanical Engineering or Biomedical preferred.
- Working knowledge and understanding of mechanical engineering practices and design principles within a regulated environment.
- Technical ability to create engineering drawings and models, applying GD&T and CAE tools.
- Demonstrated ability to apply knowledge of materials and manufacturing processes to product design.
- Knowledge of Machine Shop and 3D printing practices.
- Knowledge of Medical Device Manufacturing.