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
