Senior/Principal R&D Engineer, Catheter Development
Our client a Medical Device company who have recently established a base in Ireland are currently seeking a Senior or Principal Level R&D Engineer to join their team to work on Catheter Development. Reporting to VP of R&D the Senior/Principal R&D Engineer, Catheter Development, will be an experienced medical device engineer with intimate knowledge of medical device development for interventional cardiology. The key responsibility will be the development of the company's catheter, including the development of the design, the associated manufacturing and assembly processes, as well as the selection and management of suppliers of catheter components. The Senior R&D Engineer, Catheter Development, will work closely with his/her counterparts responsible for device characterization, other development functions, as well as quality affairs and marketing functions. The Senior Engineer, Catheter Development, will be a team player and have excellent communication skills as well as in-depth industry knowledge. Minimum of five years of medical device development experience, and have a either a primary or Master's Degree in a relevant engineering discipline such as polymer, mechanical or biomedical engineering, or equivalent experience. The Senior Engineer, Catheter Development will work from the company's office in Ireland, and be able to travel occasionally.
Essential Job Responsibilities:
• Develop design options for 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 Required Qualifications & Characteristics:
• Self-directed engineer with entrepreneurial drive
• Have an established vendor network relevant to the device type
• Experience in:
- Development of cardiovascular or equivalent devices, preferably catheter delivery systems
- Functional and mechanical test method development.
- Shaft joint design and process development www.cardiacbooster.com
- Intimate understanding of interventional cardiology device requirements, preferably structural heart applications .
Skills/Experience Master's or primary Degree in a relevant engineering discipline, or equivalent experienceMinimum of five years of medical device development experience in polymer, mechanical or biomedical engineeringDesign for Manufacture methodologiesCompetency in Solidworks or equivalent 3D CAD systemUse of insert or overmoulding techniques in catheter construction.Use of statistical analysis techniques & DOE
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