Device Engineering Group Lead
Core
Lead and develop a team of device engineers to create injection system combination products for subcutaneous drug formulations, ensuring compliance with global regulatory standards.
Role type
Senior IC device engineering group lead (medical devices)
Builds
Injection system combination products for subcutaneous drug formulations
Domain
Medical devices / Drug delivery systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Control/DHF execution, risk management (ISO 14971), V&V strategy, statistical verification protocols, CMC preparation, team leadership, stakeholder management
Preferred skills
DFSS, In-Silico first principles, audit/coaching capabilities
Technologies
21 CFR 820, ISO 13485, ISO 14971, AAMI/ANSI standards
Responsibilities
Lead and mentor a team of ~7-10 device engineers; drive consistency in device platform design standards; guide risk management and verification/validation strategy; partner with internal and external stakeholders to align execution plans; ensure deliverables meet Design Control and DHF expectations; direct development of design verification protocols and reports.
Seniority
Senior, hands-on IC with functional leadership
