Research And Development Engineer

R&D Engineer (Medical Device)Note: We do not hire C2CJob Summary:Seeking a talented R&D Engineer to design and develop new medical devices, particularly leadless pacemaker catheters. The role involves qualifying additional suppliers and ensuring compliance with regulatory standards.Key Responsibilities:Design and develop medical devices from concept to production.Conduct feasibility studies and risk assessments.Create design specifications and technical documentation.Collaborate with cross-functional teams including clinical, regulatory, manufacturing, and quality assurance.Perform prototype development, testing, and validation.Qualify additional suppliers, holding them accountable to deadlines.Support regulatory submissions and product lifecycle management.Qualifications:Bachelor's degree in biomedical engineering, Mechanical Engineering, Electrical Engineering, or a related field; Master's or Ph.D. is a plus.Minimum of 2 years of engineering experience in the medical device industry.Experience with catheter-based devices preferred.Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and MS Office.Strong understanding of medical device regulations and standards (e.g., FDA, ISO 13485, IEC 60601).Windchill experience is a plus.Strong written and verbal communication skills.Ability to work well with others and cross-collaborate effectively.

Created: 2025-02-15