Lead Mechanical Engineer I
Core
Lead Mechanical Engineer I responsible for sustaining and improving complex manufacturing systems for high-volume production in life sciences diagnostics.
Role type
Lead Mechanical Engineer (Manufacturing)
Builds
High-volume production lines for molecular diagnostic systems
Domain
Life sciences diagnostics / Medical device manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical manufacturing development, process validation, equipment qualification, root cause analysis, supplier management, DFM improvements
Preferred skills
NPI process, Design Control, CAD (Solidworks), cGMP/ISO/FDA regulations
Technologies
Solidworks
Responsibilities
Develop and maintain high-volume manufacturing documentation (BOMs, workflows, assembly plans), design and qualify manufacturing tools/fixtures/equipment, perform PFMEA and validation activities (IQ/OQ/PQ), execute root cause analysis and corrective actions, lead manufacturing scalability and cost-reduction initiatives
Seniority
Senior, hands-on IC