Key Responsibilities:
R&D Engineer for Catheter Development
We are seeking a Senior or Principal Level R&D Engineer to join our team to work on Catheter Development.
The Senior/Principal R&D Engineer, Catheter Development, will be responsible for the development of the company's catheter, including the development of the design, manufacturing and assembly processes as well as the selection and management of suppliers of catheter components.
The key responsibilities will include:
* Develop design options for the catheter
* Develop assembly and manufacturing processes for the catheter
* Anticipate risks and challenges and ensure adequate mitigation plans
* Development of risk management tools such as DFMEA and PFMEA
* 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
* Established vendor network relevant to the device type
* Experience in development of cardiovascular devices, preferably catheter delivery systems
* Functional and mechanical test method development
* Shaft joint design and process development
* Intimate understanding of interventional cardiology device requirements
Skills/Experience:
* Masters or primary Degree in a relevant engineering discipline
* Minimum of five years of medical device development experience in polymer, mechanical or biomedical engineering
* Polymer and reinforced composite Polymer Shaft design
* Design for Manufacture methodologies
* Competency in Solidworks or equivalent 3D CAD system
* Use of insert or overmoulding techniques in catheter construction
* Use of statistical analysis techniques and DOE