Senior Design Engineer | XS Innovations

XS Innovations; Leiden; On-site; EUR 75,000 - 120,000; Full time

Benefits offered by this job

Competitive compensation

Equity options

Flexible working hours

Remote work options

Cutting‑edge technology

Startup culture

Career growth

Job summary

XS Innovations in Leiden, Netherlands, seeks a Senior Design Engineer to develop a cutting‑edge Class III implantable device for treating End Stage Kidney Disease. You will collaborate with R&D, QA/regulatory, Clinical, Test, and Manufacturing to ensure safety, efficacy, and quality across the development lifecycle.

You will design from concept to production scale‑up, create CAD models, conduct verification/validation, and support manufacturing transfer in a fast‑paced startup.

Qualifications

• Bachelor's or Master's degree in Mechanical or Biomedical Engineering.
• 5+ years of full life cycle experience with Class III medical devices.
• Experience in mechanical design, prototyping and testing of vascular/implantable devices.
• Proficiency in materials science for metals and polymers used in implants.
• Familiarity with MDR, ISO 13485, ISO 14971, ISO 10993, FDA 21 CFR 820 and QMS processes.
• Excellent problem-solving skills and teamwork.

Responsibilities

• Design and develop implantable Class III medical devices from concept to production scale‑up.
• Create detailed engineering models, drawings, and specifications using CAD tools.
• Collaborate with R&D, Quality & Regulatory, Clinical, Test, and Manufacturing to meet regulations and user needs.
• Conduct feasibility studies, design of experiments, and simulations to establish robust specifications.
• Perform risk assessments and design verification/validation activities throughout the project.
• Develop and execute test protocols and document findings for regulatory submissions.
• Provide technical support to manufacturing and supply chain during design transfer and production validation.
• Stay updated with industry trends and regulatory changes.

Skills

SolidWorks

Mechanical design

Risk assessment

FMEA

Regulatory knowledge

Prototyping

Vendor management

Cross-functional teamwork

English proficiency

Education

Bachelor's or Master's in Mechanical or Biomedical Engineering

Tools

SolidWorks

3D CAD software

Job description

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, 21CFR 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 SolidWorks, 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 hard work and dedication.
• Work‑Life Balance: Benefit from flexible working hours and remote work options to fit your lifestyle.
• Innovative Projects: Engage in groundbreaking projects that have a tangible impact on patient lives.
• Dynamic Environment: Thrive in a high‑energy, fast‑paced startup environment where every day brings new challenges and opportunities.
• Collaborative Culture: Be part of a supportive and inclusive team that values collaboration and diverse perspectives.
• Career Advancement: Access numerous professional growth and development opportunities to enhance your skills and career trajectory.
• Cutting‑Edge Technology: Work with the latest technology and resources to push the boundaries of medical innovation.
• Fun and Exciting Atmosphere: Experience the excitement of working in a pioneering medtech startup where your contributions make a real difference.

Join us at XS Innovations and be a part of a team that is revolutionizing healthcare through innovation and dedication.