The R&D Engineer will be an experienced medical device engineer with a strong knowledge of medical device development for interventional cardiology or structural heart. You will work
within a dynamic R&D team tackling challenging engineering problems and generating novel solutions.
Responsibilities:
- Your key responsibility is to measure and quantify the physical characteristics of the device by experimental design along with your R&D counterparts.
- Your knowledge of solid and fluid mechanics, and other areas of physics should translate into hardware and software implementations of test platforms and their validation, including test protocols and data analysis tools.
- You will work closely with your counterparts responsible for designing and manufacturing the pVAD device suggesting design improvements based on experimental results.
- Develop new test methods in partnership with device and scientific SMEs.
- Develop test capabilities, processes and protocols to support the development, verification, and validation of the company’s catheter device.
- Document test method procedures and keep them updated in line with changes to standards.
- Develop, design, document and perform test method validations.
- Keep informed of new test standards, techniques or equipment and evaluate their impact on future or historical test data.
- Good communication with peers and management in the continuous feedback loop between device design and validation testing. Present updates and summaries of test data using statistical techniques where necessary.
- Perform demonstrations of device operation for visiting customers, new starters, executives or investors.
- Develop assembly and manufacturing processes for the company’s pVAD catheter.
- Participate in the development of DFMEA and PFMEA or similar risk management tools.
- Contribute to IP generation to protect novel developments and findings.
- Interact with third party development and manufacturing vendors.
Requirements:
- The successful candidate will have a minimum of 3 years of medical device development experience, and have either a Master’s or primary Degree in a relevant engineering/scientific discipline such as applied physics, mechanical engineering, biomedical engineering, or equivalent experience.
- Self-directed engineer with entrepreneurial drive.
- Experience in: o Use of statistical analysis techniques & DOE
- Development of 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.
- Excellent communication skills in English and preferably one other European language.
- Ability to source, evaluate and manage suppliers of equipment, calibration services and sub-contract testing.
- Experience with change control and ability to process changes efficiently. • Experience working to regulatory requirements of 21CFR820, MDR and ISO13485.
- Experience using 3D CAD modelling software (SolidWorks preferred).
- Proficient in the use of office software packages (e.g., Microsoft Outlook, Word, Excel, PowerPoint etc.).
