Project Engineer III
Core
Lead execution of high-impact engineering projects for the industrialization and commercialization of pharmaceutical products, specifically combination drug delivery systems like auto-injectors.
Role type
Senior IC project engineer (drug delivery/manufacturing)
Builds
Combination drug delivery systems, auto-injectors, and medical device packaging solutions
Domain
Biopharma / Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, design transfer, industrialization, risk assessment (FMEA), process optimization, regulatory compliance (21 CFR 820, ISO 13485), Lean Six Sigma
Preferred skills
PMP or PE certification, Lean Six Sigma certification, familiarity with combination products or medical device packaging equipment
Technologies
MS Project, AutoCAD, SAP, Excel
Responsibilities
Lead complex engineering projects from initiation through completion; manage project plans, scopes, timelines, and budgets; oversee design transfer and industrialization of drug delivery platforms; conduct risk assessments and lead process improvement initiatives; mentor junior engineers; act as a technical subject matter expert with customers and regulatory stakeholders
Seniority
Senior, hands-on IC with mentorship responsibilities