Senior Design Engineer

About us

Globally, 2.5 million patients rely on kidney dialysis machines three times a week as their lifeline. The high blood flow needed for these three-hour sessions is achieved through a surgically created connection between an artery and a vein in the arm. This permanent connection and continuous high blood flow lead to frequent complications, requiring at least bi-annual follow-up surgeries for each patient.

XS-Innovations, a pioneering medtech startup based in Leiden, is dedicated to drastically improving the quality of life for kidney patients. We are developing a cutting-edge Class III implantable valve that opens the connection between the artery and vein only when needed during dialysis. This device will be the first in a series of innovative, reliable, and life-saving technologies related to vascular access.

We seek passionate and skilled Design Engineers to join our dynamic team and contribute to the next generation of medical devices.

Job Summary

As a Senior Design Engineer, you will be instrumental in developing a cutting-edge Class III implantable device for treating End Stage Kidney Disease (ESKD). You will collaborate with engineering partners and cross-functional teams, including R&D, Quality & Regulatory, Clinical, Test, and Manufacturing, to ensure our products meet the highest standards of safety, efficacy, and quality.

Responsibilities

• Design and develop implantable Class III medical devices from concept to production scale-up.
• Create detailed engineering models, drawings, and specifications using relevant CAD software and tools.
• Collaborate with cross-functional teams to define product requirements and specifications compliant with medical device regulations and user needs.
• Conduct feasibility studies, design of experiments, and simulations to establish robust specifications.
• Perform risk assessments and design verification/validation activities as required throughout the project.
• Develop and execute test protocols, documenting findings to demonstrate device performance and compliance with requirements and relevant medical standards and regulations.
• Ensure compliance with all relevant regulatory standards (e.g., MDR, 21
  
  CFR 820, ISO 13485) and quality management systems.
• Participate in design reviews, FMEA sessions, and root cause analyses as needed.
• Provide technical support to manufacturing and supply chain teams during the design transfer and production validation process.
• Stay updated with industry trends, advancements, and regulatory changes.

Qualifications

• Bachelor’s or Master’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• 5+ years of full life cycle experience with a proven track record in developing Class III medical devices, e.g. (cardiovascular) implantable devices or ICDs, LVADs, TAVRs, catheters, pacemakers, heart valves, stents, and/or vascular grafts.
• Experience in the mechanical design, prototyping and testing of small parts used in vascular access, cardiac repair, and intervention devices.
• Proficiency in materials science, including experience with metals and polymers commonly used in implantable and delivery devices (e.g., stainless steels, nickel-titanium alloys, tantalum, cobalt-chromium alloys, platinum chromium).
• Proficiency in 3D CAD software, particularly Solid Works, and other design, simulation, and statistical analysis tools.
• Experience in developing and conducting design verification testing for the long-term viability of implantable devices and managing external suppliers and vendors.
• Familiarity with medical device regulations and standards (e.g., MDR, ISO 13485, ISO 14971, ISO 10993, FDA 21 CFR 820), quality management systems (QMS) and document control processes.
• Experience writing and delivering reports and technical summaries for clinical submissions and regulatory agencies.
• Excellent problem-solving skills and attention to detail.
• Effective communication and teamwork abilities.
• Ability to work in a fast-paced startup environment and manage multiple projects simultaneously.
• Fluency in English; additional European languages are a plus.

What we offer

• Competitive Compensation: Enjoy a competitive salary and equity options that reward…