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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior design engineer - **Company:** Rotterdam Innovation City - **Location:** Leiden, Netherlands (Remote available) - **Experience:** Expert - **Contract:** Permanent contract - **Skills:** Computer-Aided Design, Adobe InDesign, SolidWorks (CAD), Failure Mode Effects Analysis, Statistics Packages - **Published:** August 8, 2026 - **Apply:** https://clk.platform.jobster.com/?at=1786094848&b=&c=df29ac45-dcb8-4fd9-bc87-9df19656aaad&co=014bbda6-f346-47ec-b6bd-a7aebadd2953&cu=9d19ad1d-25d0-4b84-a20f-8340b86a47b4&cw=7&dt=o&fc=a&gc=a&i=9698d2ee-bc92-42d1-9cc9-408fa7011225&ic=NL&mf=c&p=47b4ebce-5907-42d5-9b5e-b30908a42d08&pm=c&po=5f8e30d1-709e-45e1-83c8-a466772a8ebf&pr=1r&r=https%3A%2F%2Fwww.jobleads.com%2Fregistration%2Fjob%3FcampaignId%3D118%26jmId%3D2377%26jobId%3De7e907fb16ca7a2e9f86dbac896f58daa%26jobLocation%3D1689534397%26utm_campaign%3Djobs%26utm_content%3Djobmarket-id%253D2377%257Clandingpage-id%253Dn%252Fa%257Cjob-id%253D7e907fb16ca7a2e9f86dbac896f58daa%257Cjob-workarea%253D09-02%257Cjob-hierarchy%253D6%257Cjob-salary-benchmark%253D4%257Cjob-industry%253D%257Cjob-location%253Dleiden%257Cjobtitle%253Dsenior-design-engineer%26utm_medium%3Djob-external%26utm_source%3Djobster%257Cr-jb%257C__Liplyn%2BIG__%257Cc-nl&s=mp&t=cl&u=ip-c96c6b498870b75e67af1437c04c5e8c&v=0253f898-1826-4816-8c57-b94b80305b79&sig=8b952ba6912ff9903e408653d90f7e50d1fb0360e5c6bee444468b82 ## About the Role * 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. ## Description 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., * 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. ## Related Videos - [From Bedside Beeps to Interoperable Bytes – Getting your medical devices ready to talk the IEEE 11073 language](https://www.wearedevelopers.com/videos/771-from-bedside-beeps-to-interoperable-bytes-getting-your-medical-devices-ready-to-talk-the-ieee-11073-language) - [Challenges of building React and React Native apps](https://www.wearedevelopers.com/videos/448-challenges-of-building-react-and-react-native-apps) - [XR Demystified: Separating Facts from Fiction in 2024](https://www.wearedevelopers.com/videos/1117-xr-demystified-separating-facts-from-fiction-in-2024) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [May I interest you in ... R?](https://www.wearedevelopers.com/videos/445-may-i-interest-you-in-r) - [Google Gemma and Open Source AI Models - Clement Farabet](https://www.wearedevelopers.com/videos/1354-google-gemma-and-open-source-ai-models-clement-farabet) ## Related Articles - [How to land a developer job in Amsterdam](https://www.wearedevelopers.com/magazine/36-how-to-land-a-developer-job-in-amsterdam) - [How to Find Tech Jobs in Amsterdam](https://www.wearedevelopers.com/magazine/279-how-to-find-tech-jobs-in-amsterdam) - [The Netherlands – Europe’s powerhouse for software development?](https://www.wearedevelopers.com/magazine/31-the-netherlands-europe-s-powerhouse-for-software-development) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [Best Companies in the Netherlands: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/193-best-companies-in-the-netherlands-top-25-companies-in-2023) - [Where to Find Entry-Level Software Engineering Jobs](https://www.wearedevelopers.com/magazine/397-where-to-find-entry-level-software-engineering-jobs)