Senior R&D Engineer

Key Responsibilities

• Lead integration-focused design and development activities for new and existing medical device technologies
• Drive interface definition, technical planning, requirements alignment, and integration execution
• Own design control documentation including DHF, traceability, risk management, V&V, and change control activities
• Support feasibility studies, prototype builds, testing, and design optimization
• Conduct root cause analysis and resolve complex technical issues
• Collaborate with Quality, Manufacturing, Regulatory, and Supplier Engineering teams to ensure successful project execution

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or related field
• 6+ years of industry experience (or 4+ years with advanced degree)
• Experience in catheter and/or single-use medical device development
• Strong understanding of design controls, risk management, V&V, DHF, and traceability
• Proven experience leading technical workstreams and working cross-functionally
• Strong communication and problem-solving skills
• Able to travel up to 15%

Preferred Qualifications

• Experience with technology/product integration projects
• Background in balloon catheter or catheter-based systems
• Experience with test method development
• Knowledge of Class II/III medical device regulations and quality systems
• Self-driven professional comfortable working in fast-paced environments