Associate Principal Scientist/Engineer, Medical Device and Combination Products, Analytical
Core
Lead analytical efforts for medical device and combination product (MDCP) development, focusing on device characterization, design verification, and mechanical test method development/validation.
Role type
Associate Principal Scientist/Engineer (Individual Contributor)
Builds
Mechanical test methods, design verification protocols, and analytical strategies for auto-injectors and pre-filled syringes.
Domain
Medical Devices / Mechanical Engineering / Analytical Science
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical Testing, Materials Characterization, Computed Tomography (CT), Rheometry, Microscopy, Design Verification, Design Validations, Device Characterization, Analytical Chemistry, X Ray Imaging
Preferred skills
Design Verification Strategies, Stability Studies, 21 CFR 820.30 (Design Controls), Engineering Studies
Technologies
Tensile/Compression/Torsional Testing Equipment, X-ray Computed Tomography, Rheometers, Microscopes
Responsibilities
Develop and own analytical strategy to satisfy Design Controls inputs; manage analytical efforts and timelines for cross-functional projects; develop and validate mechanical test methods; coordinate internal staff or external lab testing for device characterization and verification.
Seniority
Senior, hands-on IC