R&D Engineer II​/Senior R&D Engineer - Medical Devices

An established medical device manufacturer in Mecklenburg County, NC is hiring an R&D Engineer II / Senior R&D Engineer to design and develop Class II and Class III medical devices across cardiology, neurology and urology. You'll support or lead cross-functional teams from concept through commercialization. Candidates from anywhere in the U.S. who are willing to relocate are welcome, and a $10,000 relocation package is provided.

• Design and develop catheters and other medical devices from concept through production, including hands-on assembly and prototyping
• Design components, devices, tooling and fixtures in Solid Works or equivalent CAD
• Develop pilot and production tooling, fixtures, equipment and assembly processes, and support equipment qualification and validation
• Plan, execute and report verification and validation, and prepare design control documentation (protocols, reports, drawings, design history file)
• Support manufacturing with troubleshooting, process improvements and design changes
• Communicate project status, risks and technical feasibility, and work with Quality, Manufacturing, Supply Chain and Project Management
• Work with outside vendors on materials, components, tooling and processes
• Senior level: lead technical execution, mentor junior engineers and contribute to quoting and project planning

• BS or MS in Biomedical Engineering, Mechanical Engineering or a related discipline
• Engineer II: 3+ years of medical device engineering experience;
  Senior: 6+ years
• Strong medical device design and development experience; catheter experience is a big plus
• Proficiency in Solid Works or equivalent CAD, with hands-on prototyping and lab experience
• Knowledge of materials and manufacturing processes such as thermal bonding, PTFE processing and fixture design
• Experience with validation (IQ/OQ/PQ) and design controls
• Strong problem-solving and communication skills

• Engineer II: $80,000 - $110,000;
  Senior: $100,000 - $130,000
• Full benefits
• Open to candidates willing to relocate, with $10,000 relocation assistance
• Day shift, Monday to Friday, 7am - 4pm

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.