Mechanical Engineer

We are seeking an experienced Mechanical R&D Engineer with deep expertise in the EU Medical Device Regulation (EU MDR 2017/745) to join our team. This role will support the design, development, documentation, and compliance strategy for medical devices intended for the EU market. The ideal candidate has a strong engineering foundation combined with hands‑on experience navigating EU MDR requirements throughout the product lifecycle. As part of the R&D organization, you will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing to ensure that products meet both technical performance expectations and global regulatory obligations. Design & Development Lead and support remediation design activities for medical devices in accordance with EU MDR and ISO 13485. Conduct engineering studies, testing, and technical evaluations, ensuring design controls are fully aligned with regulatory requirements. Generate technical documentation including design inputs/outputs, risk analyses, verification and validation protocols, and test reports. EU MDR Compliance Develop, update, and maintain Technical Documentation (TD) and Technical Files to satisfy EU MDR Annex II and III requirements. Ensure compliance with General Safety and Performance Requirements (GSPR). Support clinical evaluation, post‑market surveillance, and post‑market clinical follow-up documentation as needed. Risk Management Perform and maintain risk management activities in alignment with ISO 14971. Lead or support FMEA, fault-tree analysis, and other risk assessment tools. Cross-functional Collaboration Work with Quality to ensure design documentation, DHFs, and updates meet internal SOPs and external regulatory standards. Support manufacturing transfer activities and design changes. Contribute to project planning, schedule development, and technical decision making. Testing & Verification Design and execute verification and validation (V&V) testing to demonstrate safety, performance, and regulatory compliance. Lead investigations of design issues, CAPAs, and nonconformances impacting EU markets. Required Bachelor’s or Master’s degree in Mechanical, Biomedical, Electrical, or related Engineering field. 3–7+ years of experience in R&D within the medical device industry. Demonstrated experience preparing EU MDR–compliant technical documentation. Strong understanding of design controls (21 CFR 820.30), ISO 13485, ISO 14971, and IEC/ISO standards related to the product type. Proven experience interacting with Notified Bodies or supporting NB audits. Excellent technical writing skills and ability to produce audit‑ready documentation. Preferred Experience with Class IIb or Class III medical devices. Prior experience with EU MDD-to-MDR transition projects. Experience with coordinating with Regulatory Affairs to address Notified Body questions, audits, and remediation actions. SolidWorks and Windchill experience. Experience following IEC 60601 medical electrical equipment safety requirements. Soft Skills Strong problem‑solving and analytical abilities. Ability to communicate complex technical topics clearly to both technical and non‑technical audiences. Collaborative mindset with ability to work cross‑functionally in a regulated environment. Highly organized with strong attention to detail. Pay: $54.00 - $57.00 per hour Benefits: 401(k) Dental insurance Flexible schedule Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance Work Location: Remote