R&D Engineer

We are seeking a hands-on Staff R&D Engineer to join a fast growing medical device team focused on developing innovative, neurovascular catheter based technologies. This role will play a critical part in advancing products through the full design control lifecycle, from early concept development and prototyping through verification, validation, and manufacturing transfer.

The ideal candidate thrives in a collaborative, cross functional environment and brings strong technical depth, structured problem solving skills, and a passion for building high quality Class II and Class III medical devices.

• Lead product design efforts from early feasibility, concept generation, and prototyping through design transfer
• Develop and refine prototypes in collaboration with internal engineering teams and external suppliers
• Translate clinical insights, physician feedback, pre clinical study results, and market requirements into robust engineering solutions
• Drive iterative design improvements based on bench testing, simulated use models, and early evaluation data

• Own and support design control activities including design planning, design freeze, verification, and validation
• Contribute to risk management activities in accordance with ISO 14971, including FMEA development, CAPA support, and change control documentation
• Generate and maintain clear, audit ready technical documentation aligned with ISO 13485 and FDA Quality System Regulations

• Support manufacturing through process development, fixture design, troubleshooting, and yield improvement initiatives
• Develop technical documentation including test protocols, reports, and manufacturing process instructions
• Partner closely with Operations and Quality to ensure seamless transition from development into production

• Develop test methods, anatomical models, and evaluation protocols to support pre clinical and bench testing
• Analyze data to inform design decisions and drive continuous improvement
• Provide technical input for device investigations and procedural development

• Collaborate with Engineering, Quality, Clinical, Marketing, and Commercial teams to improve product safety, reliability, and performance
• Serve as a technical resource for internal stakeholders and external partners

• Bachelor’s degree or equivalent experience in Mechanical Engineering, Biomedical Engineering, or related field
• 5+ years of medical device design and development experience
• Proficiency in Solid Works or similar CAD software
• Working knowledge of ISO 13485 and FDA Quality System Regulations
• Strong analytical, documentation, and problem solving skills

• Experience in early stage or growth stage medical device companies
• Hands on prototyping, fixture development, and bench testing experience
• Familiarity with risk management tools such as FMEA and structured design control processes