Lead Mechanical Engineer II
Core
Sustaining and improving complex manufacturing systems for high-volume production of molecular diagnostic systems.
Role type
Lead Mechanical Engineer II (Manufacturing Engineering)
Builds
High-volume production lines for medical diagnostic instruments
Domain
Life sciences / Medical devices / Manufacturing
Required skills
Mechanical manufacturing development, Process validation, Equipment qualification, PFMEA, Root cause analysis, Supplier quality management, DFM, Regulatory compliance (cGMP/ISO/FDA), CAD
Preferred skills
NPI process, Design Control, Solidworks
Technologies
Solidworks, CAD
Responsibilities
Develop and maintain high-volume manufacturing documentation (BOMs, workflows, assembly plans), Design and qualify manufacturing tools and fixtures, Perform validation activities (IQ/OQ/PQ) and risk assessments, Execute root cause analysis and corrective actions, Lead scalability and cost-reduction initiatives with suppliers
Seniority
Senior, hands-on IC