Associate Principal Scientist Engineer, Drug and Device Combination Products (Onsite)
Core
Leading method development, validation, and transfer for functional testing of medical devices and combination products to support clinical and commercial stability.
Role type
Associate Principal Scientist / Engineer (Method Development & Transfer)
Builds
Functional test methods and validation protocols for device characterization and design verification
Domain
Pharmaceutical/Medical Device Industry (Combination Products)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Method development, Validation, GMP Compliance, Design Failure Mode and Effect Analysis (DFMEA), Mechanical Testing, Quality Management Systems (QMS), Project Management
Preferred skills
Team leadership, Regulatory knowledge, Cross-functional collaboration
Technologies
GMP facilities, QMS tools, Mechanical testing equipment
Responsibilities
Lead technical strategy for method development and validation; Execute method transfer to internal and external GMP nodes; Manage and develop a team of 4-5 scientists/engineers for routine functional testing
Seniority
Senior, hands-on IC with team management
