Job Opportunity:
We are seeking a talented Senior Research and Development Engineer to lead our technical development efforts from concept to commercialization.
The successful candidate will be responsible for designing, prototyping, and testing medical devices while maintaining regulatory compliance and driving innovation.
Key Responsibilities:
* Medical Device Design and Development: Design and develop Class II/III medical devices, ensuring they meet safety and efficacy standards.
* Regulatory Compliance: Drive the creation of design history files (DHF) and maintain compliance with FDA and ISO 13485 regulations.
* Risk Analysis and Validation: Perform risk analysis (FMEA), verification & validation (V&V), and root cause analysis to ensure product quality and reliability.
* Collaboration and Leadership: Partner with cross-functional teams to drive innovation and mentor junior engineers.
Requirements:
* Bachelor's or Master's degree in Mechanical, Biomedical, or related Engineering field.
* Strong engineering background and problem-solving skills.
* 4+ years of experience in medical device R&D, preferably with implantable or diagnostic device experience.
* Proven track record of taking devices from concept to market.
* Knowledge of design controls, regulatory requirements, and quality systems.
* Proficiency in CAD tools (SolidWorks or equivalent) and statistical tools (Minitab, JMP).
* Exceptional problem-solving, communication, and collaboration skills.
What We Offer:
* A dynamic work environment focused on innovation and excellence.
* Competitive compensation and benefits package.
* Ongoing training and development opportunities.