Job Description
Join MedTech Innovations as a Senior Medical Device Engineer and revolutionize healthcare through cutting-edge technology. We're seeking a passionate innovator to lead the development of next-generation medical devices that transform patient outcomes. In this pivotal role, you'll collaborate with multidisciplinary teams to design, test, and bring life-changing solutions to market. Our culture emphasizes creativity, precision, and patient-centric innovation. Enjoy competitive benefits, flexible work arrangements, and opportunities to present at industry conferences.
Responsibilities
- Lead end-to-end design and development of FDA-compliant medical devices
- Conduct rigorous testing protocols including biocompatibility and validation studies
- Mentor junior engineers and cross-functional teams on quality standards
- Manage product lifecycle from prototype to commercial launch
- Ensure adherence to ISO 13485 and GMP regulations
- Collaborate with clinical teams for real-world feedback integration
- Present technical documentation to regulatory bodies
Qualifications
- Master's degree in Biomedical Engineering or related field
- 5+ years of medical device development experience
- Proven expertise in CAD software (SolidWorks preferred)
- FDA regulatory affairs knowledge and compliance experience
- Strong analytical skills for failure mode analysis
- Certification in ISO 13485 quality management systems
- Experience with human factors engineering and usability testing
- Excellent communication and documentation abilities