descripción del trabajo

Design Assurance Engineer – Active Implantable Devices

A fast-growing medical device startup on a mission to redefine treatment through next-generation active implantable technologies. Backed by leading investors and clinical collaborators, they are developing breakthrough solutions that merge miniaturized electronics, biocompatible design, and smart therapy delivery to improve lives. They are seeking a Design Assurance Engineer with strong experience in active implantable medical devices (AIMDs) to help build a robust and compliant design and development program.

Role Summary

You will be the Quality & Design Assurance voice embedded in our Quality team ensuring that design inputs, risk management, verification, and validation activities meet the highest standards of safety, performance, and compliance. This is a hands-on role ideal for someone excited to contribute to every phase of a product’s lifecycle in a startup environment.

Responsibilities

• Lead Design Assurance activities throughout the product lifecycle (from feasibility to post-market)
• Ensure compliance with ISO 13485, ISO 14708-3 ISO 14971, IEC 60601/62304, and AIMD-specific requirements (e.g., ISO 14708, EU MDR, FDA 21 CFR 820)
• Support the development and review of:
• Design Inputs & Outputs
• Design Verification & Validation (V&V) plans and protocols
• Risk Management Files (per ISO 14971)
• Usability Engineering documentation (IEC 62366)
• Partner with R&D and Systems Engineering to drive DFMEA, PFMEA, and Hazard Analysis
• Lead traceability matrix development and DHF documentation
• Ensure product development adheres to AIMD-specific testing (biocompatibility, electrical safety, EMC, software)
• Participate in supplier qualification and component change evaluation
• Support regulatory submissions (IDE, 510(k), PMA, CE Technical File) with relevant design assurance inputs
• Contribute to QMS development/improvement as needed in a growing organization

Requirements:

• Bachelor’s or Master’s in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related field
• 3–7+ years of experience in design assurance / quality engineering in implantable medical devices, preferably Class III / AIMD
• Deep understanding of applicable standards: ISO 14708, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, FDA QSR, EU MDR
• Hands-on experience supporting design controls, risk management, and V&V testing
• Experience in start-up or fast-paced R&D environments

Preferred:

• Experience with neuromodulation, cardiac, neurostimulators, or drug delivery implants
• Familiarity with software as a medical device (SaMD) or embedded firmware
• Experience supporting clinical builds, IDE submissions, or early feasibility studies (EFS)