Design Assurance Engineer

Skills Alliance; Madrid; Presencial; EUR 40.000 - 70.000; Jornada completa

Descripción de la vacante

A growing medical device startup in Madrid is seeking a Design Assurance Engineer to lead quality activities throughout product lifecycles. Ideal candidates have 3-7 years of experience with active implantable medical devices and are knowledgeable in compliance with ISO and FDA standards. This role offers a fast-paced startup environment emphasizing hands-on contributions to design and quality assurance processes.

Formación

• 3–7+ years of experience in design assurance/quality engineering for implantable medical devices.
• Deep understanding of applicable standards: ISO 14708, ISO 13485, ISO 14971.
• Hands-on experience supporting design controls and risk management.

Responsabilidades

• Lead Design Assurance activities throughout the product lifecycle.
• Ensure compliance with ISO and FDA requirements.
• Participate in supplier qualification and regulatory submissions.

Conocimientos

Experience in design assurance

Knowledge of ISO standards

Risk management

Verification and validation testing

Familiarity with biomedical devices

Educación

Bachelor’s or Master’s in Biomedical Engineering

Descripción del empleo

Get AI-powered advice on this job and more exclusive features.Direct message the job poster from Skills AllianceDesign Assurance Engineer – Active Implantable DevicesA 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 SummaryYou 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.ResponsibilitiesLead 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 & OutputsDesign Verification & Validation (V&V) plans and protocolsUsability Engineering documentation (IEC 62366)Partner with R&D and Systems Engineering to drive DFMEA, PFMEA, and Hazard AnalysisLead traceability matrix development and DHF documentationEnsure product development adheres to AIMD-specific testing (biocompatibility, electrical safety, EMC, software)Participate in supplier qualification and component change evaluationSupport regulatory submissions (IDE, 510(k), PMA, CE Technical File) with relevant design assurance inputsContribute to QMS development / improvement as needed in a growing organizationRequirements :

Bachelor’s or Master’s in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related field3–7+ years

of experience in

design assurance / quality engineering

implantable medical devices, preferably

Class III / AIMDDeep understanding of applicable standards :

ISO 14708, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, FDA QSR, EU MDRHands-on experience supporting design controls, risk management, and V&V testingExperience in start-up or fast-paced R&D environmentsPreferred :

Experience with

neuromodulation, cardiac, neurostimulators, or drug delivery implantsFamiliarity with

software as a medical device (SaMD)

or embedded firmwareExperience supporting

clinical builds, IDE submissions, or early feasibility studies (EFS)Seniority level

Seniority level Mid-Senior levelEmployment type

Employment type Full-timeJob function

Job function Quality AssuranceIndustries Medical Equipment ManufacturingReferrals increase your chances of interviewing at Skills Alliance by 2xSign in to set job alerts for “Design Assurance Engineer” roles.

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