Job Description
Join MedTech Innovations as a Senior Medical Device Engineer and lead the development of next-generation healthcare solutions. We're seeking a visionary professional to design, test, and validate cutting-edge medical devices that improve patient outcomes. Enjoy competitive compensation, comprehensive benefits, and the opportunity to transform healthcare through innovation. Apply today to be part of a dynamic team shaping the future of medicine.
Responsibilities
- Design and develop innovative medical devices from concept to FDA submission
- Lead cross-functional teams in prototyping, testing, and validation processes
- Ensure compliance with ISO 13485, FDA regulations, and industry standards
- Conduct risk analysis and mitigation strategies for all device components
- Collaborate with clinical partners to translate user needs into technical specifications
- Manage product lifecycle documentation including design history files
- Stay current with emerging technologies and regulatory trends in medical devices
Qualifications
- Bachelor's degree in Biomedical, Mechanical, or Electrical Engineering (MS/PhD preferred)
- 5+ years of experience in medical device development with 2+ years in leadership
- Proven track record of bringing Class II/III devices to market
- Expertise in CAD (SolidWorks), FEA analysis, and rapid prototyping
- Strong understanding of FDA QSR, ISO 13485, and risk management (ISO 14971)
- Experience with human factors engineering and usability testing
- Certification in Quality Systems Auditing (CQA) or Six Sigma preferred
- Excellent problem-solving skills with attention to regulatory compliance