Design Quality, Late-Stage Development Manager
Core
Lead quality and design control for New Product Introduction (NPI) of combination products and medical devices (infusion pumps, tubing, drug administration systems) to ensure on-time delivery, compliance, and profitability.
Role type
Senior Manager, Design Quality & Late-Stage Development
Builds
Combination products and medical devices for AbbVie plants, third-party manufacturers, and licensing/co-marketing partners.
Domain
Medical Devices / Combination Products / Regulatory Quality
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control, root cause investigation, CAPA, statistics and data analytics, risk management, regulatory compliance (device/drug/biologics), supplier quality management, audit readiness, cross-functional leadership
Preferred skills
Experience with sterile/unsterile devices, technical agreement negotiation, process gap identification, global team collaboration
Technologies
None explicitly listed
Responsibilities
Mentor product teams through the design process; lead cross-functional teams for solution development; participate in design reviews and ensure design control documentation; assess impact of changes on safety and efficacy; support regulatory inspections and audits; develop global Product Quality Assurance strategy; facilitate new product launches; negotiate quality agreements with suppliers; manage pre-approval inspection readiness.
Seniority
Senior, hands-on IC with leadership responsibilities