JCW Group
Overview:
Seeking a Principal R&D Engineer to lead medical device product development from concept through commercialization. This role drives cross-functional teams, mentors engineers, and plays a strategic role in shaping both products and processes.
Responsibilities: Lead design and development of new devices in alignment with quality system and regulatory requirements Translate user needs into validated designs with clear specifications and robust test methods Oversee verification, validation, and design transfer activities Guide design reviews and ensure timely completion of deliverables Manage multiple projects and act as primary technical contact for leadership Mentor engineers and potentially supervise direct reports Collaborate with physicians, suppliers, and cross-functional teams Identify department-level process improvements and contribute to product strategy Support product line extensions and continuous improvement initiatives
Qualifications: Bachelors degree in Engineering or related field 7+ years of product development experience in the medical device industry Strong background in design controls, test method development, and materials/process selection Skilled in CAD (SolidWorks), lab tools, and statistical methods Proven leadership and cross-functional team management experience Working knowledge of applicable U.S. and international medical device standards
Preferred: Expertise in catheter or minimally invasive device design and fabrication Experience from concept through commercialization Strong project management and mentoring capabilities
Responsibilities: Lead design and development of new devices in alignment with quality system and regulatory requirements Translate user needs into validated designs with clear specifications and robust test methods Oversee verification, validation, and design transfer activities Guide design reviews and ensure timely completion of deliverables Manage multiple projects and act as primary technical contact for leadership Mentor engineers and potentially supervise direct reports Collaborate with physicians, suppliers, and cross-functional teams Identify department-level process improvements and contribute to product strategy Support product line extensions and continuous improvement initiatives
Qualifications: Bachelors degree in Engineering or related field 7+ years of product development experience in the medical device industry Strong background in design controls, test method development, and materials/process selection Skilled in CAD (SolidWorks), lab tools, and statistical methods Proven leadership and cross-functional team management experience Working knowledge of applicable U.S. and international medical device standards
Preferred: Expertise in catheter or minimally invasive device design and fabrication Experience from concept through commercialization Strong project management and mentoring capabilities