Engineer II, Manufacturing Engineering
Core
Design, optimize, and validate manufacturing processes for clinical diagnostic reagents in a regulated environment.
Role type
Manufacturing / Industrial / Process Engineer
Builds
High-volume and high-mix manufacturing lines for clinical diagnostic reagents
Domain
Medical Device / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical design aptitude, cGMP/ISO regulatory knowledge, Lean manufacturing principles, Statistical analysis, Root cause investigation, CAD software proficiency, Engineering documentation, Change control processes, Equipment qualification, Process validation
Preferred skills
Automation and controls design, Lean Six Sigma Green/Black belt, Aseptic processing knowledge, Reagent formulation knowledge
Technologies
CAD software, Manufacturing systems, Data analysis tools
Responsibilities
Support daily manufacturing operations for product quality and yield, Develop and validate manufacturing processes for formulation and packaging, Author and revise controlled documents like SOPs and validation protocols, Participate in process validation activities (IQ/OQ/PQ), Investigate deviations and lead root cause analysis, Monitor process performance using statistical tools, Collaborate with cross-functional teams for regulatory compliance, Assist with change control activities and risk assessments, Maintain accurate documentation per data integrity standards, Develop equipment tooling design improvements and automation
Seniority
Mid-level IC (2-3 years experience)
