Our client is a young MedTech start-up company located in Belgium. They develop innovative products in the coronary business. The Company is financially backed by strong international investors and shows great business ambition.
In order to lead strategic R&D projects critical to the Company, we are looking for a (m/f):
R&D Engineer – Catheter
As a R&D Engineer – Catheter, you will lead and take care of designing, developing and testing next-generation catheter delivery systems from concept to human use. Reporting to the Senior Director R&D you play a key role in the R&D/innovation activities.
Your main responsibilities are:
- Conceptualize, design and develop innovative interventional catheters, including design requirements, prototype developments, pre-clinical and clinical assessments, and industrialization.
- Support the design of the next generation catheter components, in collaboration with Quality.
- Support the development of new test methods, tooling and equipment procurement, and executing long term testing for catheters.
- Collaborate with colleagues and physicians in both pre-clinical and clinical developments in order to evaluate technology and to have a better understanding of cardiovascular anatomy.
- Work with team members and external partners to deliver project’s technical objectives.
- Report results and work evolution on a regular basis to the top management.
- Establish timelines and ensures adherence to timely execution.
- Develop appropriate test methods for product evaluations, write and execute test protocols and test reports required per GMP and regulatory submissions.
- Mechanical or Biomedical Engineering Master’s degree.
- 3 to 10 years’ experience in design, development and industrialization within medical device companies.
- Experience in materials (plastics, adhesives and associated processes), and mechanical (small part) design.Experience with catheters is a strong asset.
- Experience in medical device regulatory requirements, QMS and design control processes is an asset.
- Relevant technical expertise on extrusion, braiding, molding, and bonding processes.
- Proven record of working with and managing vendors for product and process specification and testing.
- Strong innovation and communication skills together with hands-on and pragmatic mind-set.
- Very good organizational, analytical and problem-solving skills.
- Highly collaborative, self-motivated and team-oriented individual in a company setting.
- Excellent oral and written communication skills in English. Any other language is a plus.
- Up to 25% travel may be required.
- A challenging position with a high potential innovative medical device company.
- To work in a human-sized, collaborative and respectful environment.
- A variety of interesting contacts with international exposure.
- An attractive compensation package in line with your responsibilities and experience.