Job Overview
* We seek a highly skilled and motivated R&D Tech Lead/Staff Engineer to drive innovation and excellence in the development of cutting-edge medical products and technologies.
About the Role
* The R&D Tech Lead/Staff Engineer plays a critical role in guiding cross-functional teams through every stage of the product lifecycle—from concept development to commercialization and post-market support.
* This position combines deep technical expertise with leadership and systems engineering, overseeing system design, development, requirements architecture, integration, testing, documentation, and regulatory compliance.
Main Responsibilities
* Lead system-level design and development for new and existing medical products, ensuring alignment with stakeholder needs.
* Define product architectures and translate stakeholder inputs into clear, traceable system requirements.
* Oversee system integration and testing activities, supporting verification and validation across hardware, software, UX, and systems.
* Provide mentorship and technical guidance to cross-functional teams, promoting engineering excellence.
* Own and maintain design control documentation, SOPs, and requirements using tools like DOORS and Modern Requirements.
* Ensure compliance with ISO 13485, ISO 14971, FDA QSR, and support FDA submissions through collaboration with quality and regulatory teams.
Required Skills and Qualifications
* Proven experience in leading technical project teams (HW, SW, UX, Systems) through the product lifecycle and phase-gate approach.
* Strong ability to lead large teams and communicate technical deliverables effectively.
* Experience in writing SOPs, guidance, and technical documentation.
Benefits
* Collaborative work environment that fosters innovation and growth.
* Opportunities for professional development and career advancement.