R&d Engineer

Job Title:

R&D Engineer - EU Medical Device Regulation (EU MDR)

Job Description

This role focuses on leading research and development activities for medical devices intended for the EU market, with a strong emphasis on compliance with the EU Medical Device Regulation (EU MDR 2017/745). You will drive design, development, documentation, and regulatory strategy to ensure products meet both technical performance requirements and global regulatory obligations. Working as part of an R&D organization, you will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing teams to deliver safe, effective, and compliant medical devices throughout the product lifecycle.

Responsibilities

* Lead and support remediation design activities for medical devices in accordance with EU MDR 2017/745 and applicable international standards.

* Conduct engineering studies, testing, and technical evaluations to ensure that design controls fully align with regulatory and quality system requirements.

* Generate comprehensive technical documentation, including design inputs and outputs, risk analyses, verification and validation protocols, test reports, and other design control records.

* Develop, update, and maintain Technical Documentation and Technical Files to satisfy EU MDR Annex II and Annex III requirements.

* Ensure that designs and documentation comply with General Safety and Performance Requirements (GSPR) under EU MDR.

* Support the creation and maintenance of clinical evaluation, post‑market surveillance, and post‑market clinical follow‑up documentation as needed.

* Perform and maintain risk management activities in alignment with relevant ISO risk management standards for medical devices.

* Lead or support risk assessment activities such as Failure Modes and Effects Analysis (FMEA), fault‑tree analysis, and other structured risk tools.

* Collaborate with Quality to ensure that design documentation, Design History Files (DHFs), and updates meet internal standard operating procedures and external regulatory expectations.

* Support manufacturing transfer activities and design changes to ensure robust, compliant, and efficient production processes.

* Contribute to project planning by providing input on schedules, technical risk, design strategies, and key decision points.

* Design and execute verification and validation (V&V) testing to demonstrate product safety, performance, and regulatory compliance.

* Lead investigations of design issues, corrective and preventive actions (CAPAs), and nonconformances impacting EU markets, including root cause analysis and implementation of effective solutions.

* Collaborate with Regulatory Affairs to support Notified Body audits, address questions, and contribute to remediation actions related to EU MDR compliance.

Essential Skills

* Bachelor's or Master's degree in Mechanical, Biomedical, Electrical, or a related engineering field.

* Several years of experience in research and development within the medical device industry, working on regulated products.

* Demonstrated experience preparing EU MDR-compliant technical documentation for medical devices intended for the EU market.

* Strong understanding of design controls, including requirements comparable to 21 CFR 820.30, and their application throughout the product lifecycle.

* Hands‑on experience working with ISO and IEC/ISO standards relevant to medical devices and the specific product type.

* Proven experience interacting with Notified Bodies or supporting Notified Body audits, including preparation and defense of technical documentation.

* Excellent technical writing skills with the ability to produce clear, complete, and audit‑ready documentation.

* Ability to plan, execute, and document engineering studies, verification and validation testing, and risk management activities.

* Strong cross‑functional collaboration skills, with experience working alongside Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing teams.

Additional

Skills & Qualifications

* Experience working with Class IIb or Class III medical devices.

* Prior involvement in EU Medical Device Directive (MDD) to EU MDR transition projects.

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