Medical Devices R&D Tech Lead
Synergize with cross-functional engineering teams to propel system-level design for new and existing medical devices. Translate stakeholder needs into clear, traceable requirements, and provide mentorship across disciplines.
* Create system-level designs that meet regulatory standards.
* Transform stakeholder demands into transparent system requirements.
* Oversee integration and testing processes across diverse teams.
* Offer technical guidance and leadership to engineering teams.
* Maintain and develop design control documentation, SOPs, and requirements using tools like DOORS or Modern Requirements.
* Manage change control and configuration management procedures (e.g., CCB, CIT).
* Support regulatory submissions (FDA, ISO 13485, ISO 14971) in collaboration with Quality and Regulatory departments.
* Conduct risk assessments including dFMEA and hazard analysis.
* Collaborate closely with Quality, Manufacturing, Marketing, and Regulatory teams to ensure smooth product development.
* Develop Excel-based tools and workflows to enhance efficient documentation and project tracking.
Key qualifications include 5+ years of experience in product development, preferably in medical devices, a strong background in systems engineering, and a proven track record of leading technical teams through phase-gate processes.