Xeltis is looking for a Senior R&D Engineer to contribute to the design and development of next generation bioresorbable vascular grafts which utilize endogenous tissue restoration (ETR).
Xeltis is a clinical stage medical device company with the world’s most advanced polymer-based platform of restorative cardiovascular devices. Xeltis’ devices naturally evolve into living blood vessels or heart valves within the body through patient’s own tissue.
The company has a young team of 40 employees from all over the world. “Improving patients’ lives” is what drives us to work with joy on a daily basis.
Who are we looking for?
The Senior R&D Engineer will play a key role in a cross-functional product development team, focusing on chemical process engineering, polymeric biomaterial manufacturing, testing, production and overall support in an early clinical phase of the product.
Position reports to the VP of R&D and is based in Eindhoven, The Netherlands.
- Design and develop next generation vascular graft devices comprising electro-spun bioresorbable polymers for the purpose of facilitating endogenous tissue restoration (ETR).
- Responsible for generation and execution of deliverables related to medical device design controls, including material specifications, drawings, design inputs, FMEAs, test plans, reports and design verification activities.
- A senior technical team member in a small team of engineers, scientists and technicians. Must be able to translate theoretical test concepts into reality.
- Working closely with project team members in Operations, Regulatory, Quality, and Clinical to deliver project objectives.
- Provide leadership for the design control elements of the project.
- Develop and qualify test methods and procedures to be used in device qualification testing.
- Develop timelines for projects and ensure goals are being met.
- Compile and analyse data, prepare documentation, and make recommendations for changes and/or improvements.
- Generate test protocols, reports and supporting documentation for design verification purposes.
- Other duties as required
- Candidates must possess a bachelors or advanced degree in Engineering or a Scientific discipline from an accredited College or University.
- Proven record of success in managing details in a regulated environment.
- Minimum of 5+ years of industry experience in medical device development.
- Knowledgeable in medical device design controls and quality systems per ISO 13485.
- Must be a highly motivated self-starter able to achieve results with minimal direction.
- Demonstrated leadership skills providing work direction to a multi-functional team including internal and external resources.
- Proven track record of ability to resolve complex problems.
- The ability to work well with other groups in a collaborative environment.
- Must be proactive and creative in solving technical problems.
- Deep understanding of chemical engineering, with specialization in polymers.
- Deep understanding of industry standards for chemical and polymer processing.
- Experience in prior cardiovascular medical device projects is preferred.
- Experience in electrospinning is preferred.
- Excellent written and spoken English communication skills.
The position is full-time. For more information and to submit your CV and motivational letter, please contact: email@example.com