Senior Design Engineer- Implantable Medical Devices (Remote)

XS Innovations; Leiden; Hybrid; 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

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.