Staff Research Scientist
Core
Lead Design Control for developing new regulated molecular diagnostic products and managing lifecycle of existing products, ensuring compliance with FDA and global regulatory standards.
Role type
Staff Research Scientist (Design Control Lead)
Builds
Class III medical devices (molecular diagnostics)
Domain
Healthcare / Molecular Diagnostics / Regulatory Affairs
Required skills
Design control management, PMA/IVD development, assay design, analytical and clinical validation strategy, risk management, regulatory compliance (FDA/ISO), cross-functional leadership, root cause analysis, technical reporting, mentorship
Preferred skills
Bioinformatics, next-generation sequencing (NGS), nucleic acid analysis
Technologies
PMA, IVD, NGS, ISO 13485, ISO 14971, QSR
Responsibilities
Lead overarching product development activities within the FDA Design Control framework; Own creation and versioning of the Design and Development Plan; Manage Design History File (DHF) documentation; Apply hands-on experience with PMA and/or IVD molecular diagnostics test development; Define product development project goals and deliverables; Provide scientific and technical leadership across all phases of product development; Provide oversight and management of cross-functional project teams; Represent R&D in project/program cross-functional core team meetings; Collaborate cross-functionally with Product Management, Program Management, Clinical Affairs, Regulatory Affairs, Quality, Manufacturing, and Clinical Testing Laboratory teams; Analyze and interpret complex experimental data; Prepare detailed technical reports and validation summaries; Lead root cause analysis and risk-based investigations; Mentor and train team members on design control processes.
Seniority
Staff, hands-on IC with leadership responsibilities