Lead Scientist Product
Core
Lead product systems development for FDA Class II regulated medical devices (e.g., tampons, pessaries, pads) from early innovation through post-market surveillance.
Role type
Senior IC product development scientist (medical devices)
Builds
FDA Class II medical device products and systems
Domain
Consumer health products / Medical devices
Required skills
Product development lifecycle management, Design controls, Risk management, Specification management, Process validation, Cross-functional team leadership, Project budget and timeline management, Root cause analysis, Medical device testing methods
Preferred skills
Class I and II medical device development experience, Consumer goods material development cycles, Knowledge of feminine hygiene products, ETQ systems, Quality Management Systems (QMS), Global stakeholder management
Technologies
ETQ
Responsibilities
Lead product systems development efforts across the FDA Class II regulated product development cycle, Execute Product Development processes including design controls and risk management, Guide cross-functional teams through design control processes, Lead development of product key milestones and resource forecasts, Facilitate discussions with marketing regarding claims and aesthetics, Provide mentorship to junior team members, Identify complex technical issues and develop solutions
Seniority
Senior, hands-on IC