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Senior Catheter Development Engineer
3 weeks ago
We are seeking a highly skilled Senior or Principal Level R&D Engineer to work on catheter development.
Responsibilities:- Develop design options for the company's catheter
- Develop assembly and manufacturing processes for the company's catheter
- Anticipate risks and challenges, proactively ensure availability of adequate mitigation plans
- Development of DFMEA and PFMEA or similar risk management tools
- Work with management and marketing function to ensure adequate input from physician advisors
- Ensure adequate IP generation to protect novel developments and findings
- Manage relationships with third-party development and manufacturing vendors
- Self-directed engineer with entrepreneurial drive
- Established vendor network relevant to the device type
- Experience in cardiovascular or equivalent devices, preferably catheter delivery systems
- Functional and mechanical test method development
- Shaft joint design and process development
- Intimate understanding of interventional cardiology device requirements, preferably structural heart applications
The ideal candidate will have a Master's or primary Degree in a relevant engineering discipline, or equivalent experience. A minimum of five years of medical device development experience in polymer, mechanical or biomedical engineering is also required. Strong skills in Design for Manufacture methodologies, Solidworks, and statistical analysis techniques & DOE are essential.
