Senior R&D Engineer – Medical Devices / MedTech

Shape the future of cardiovascular healing

At Xeltis, we develop innovative, bioresorbable vascular implants designed to support the body’s natural healing processes.

Our devices provide temporary mechanical support and gradually resorb, enabling natural tissue formation over time. This approach challenges conventional implant design and requires advanced modelling, rigorous engineering, and deep understanding of both mechanics and biology.

To strengthen our R&D organization, we are looking for a Senior R&D Engineer who wants to see advanced simulations and engineering decisions translate into safe, compliant, and clinically meaningful medical devices.

Why this role exists

As Senior R&D Engineer, you provide technical leadership in Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD) by defining modelling strategies, critically interpreting externally generated results, and guiding design decisions, design controls, and verification activities for Class III cardiovascular medical devices.

This role is ideal if you:

• Enjoy owning complex technical challenges

• Want real influence over device design and development

• Are motivated by seeing work move from concept → verification → clinical validation

• Are transitioning from academia or research into medical device industry, or already have industry experience

You will operate in an international, cross-functional R&D environment with a high level of trust and responsibility.

What you’ll work on

You will contribute across multiple Medical Device R&D programs, including:

• Acting as the FEA / CFD Subject Matter Expert within Xeltis

• Defining modelling strategies for vascular implants

• Reviewing and guiding outsourced FEA and CFD analyses

• Interpreting simulation results and translating them into clear design recommendations

• Presenting technical outcomes to R&D leadership and management

• Designing and developing bioresorbable cardiovascular implants

• Concept generation, CAD design, prototyping, and iterative development

• Developing and validating test methods (FEA, bench testing, pre-clinical studies)

• Leading verification and validation sub-activities

• Supporting risk management and design control activities (ISO 13485, 14791, FMEA)

• Preparing audit-ready technical documentation (Design History Files, drawings, reports)

• Supporting regulatory submissions (MDR/CE, FDA, BSI)

• Collaborating closely with Regulatory Affairs, Quality Assurance, Operations, and Clinical teams

You will typically manage multiple projects in parallel, with autonomy to propose solutions and drive continuous improvement.

What makes this role distinctive

• You define modelling strategies, not just execute them

• You have technical decision autonomy impacting product design and development

• You work independently on complex R&D challenges with appropriate support

• You contribute across the full medical device product life cycle

• Your work directly affects patient safety and long-term clinical outcomes

Who we’re looking for

We welcome candidates from industry or a hybrid background.

You likely bring:

• A Bachelor’s degree or higher in Engineering, Biomedical Engineering, or a related science

• At least 5 years of relevant experience, including a minimum of 3 years in the MedTech industry (preferably with Class II or Class III medical devices)

• Strong experience in non-linear FEA and CFD for medical or vascular devices

• Experience with bioresorbable polymers, nitinol, or Co-Cr stents (strong plus)

• Experience working in or exposure to regulated environments

• Knowledge of ISO 13485, and EU/US regulatory pathways (advantage)

• Experience with verification & validation, Design of Experiments, RCA, and risk management (ISO 14971)

Equally important:

• You can explain complex analyses clearly to diverse stakeholders

• You enjoy cross-functional and cross-cultural collaboration

• You combine analytical depth with pragmatic engineering judgment

• You care deeply about quality, compliance, and patient safety

Why Xeltis?

At Xeltis, you’ll find:

• A mission-driven, international MedTech team

• Real ownership and trust in technical decision-making

• Exposure to the entire medical device development journey

• The opportunity to shape therapies that genuinely change lives

This is not a supporting role.
This is a role where your engineering expertise directly shapes outcomes.

Interested?

If our mission resonates with you, even if you don’t meet every requirement, we’d love to hear from you.

Let’s explore whether your experience, curiosity, and ambition belong at Xeltis.