Medical Device Manufacturing Engineer: Process Excellence

Energy Jobline ZR

Menlo Park (CA)

On-site

USD 120,000 - 170,000

Full time

9 days ago

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Job summary

Energy Jobline ZR in Menlo Park is seeking an experienced manufacturing engineer to lead design, validation, and scale-up of catheter production processes. This role emphasizes process validation (IQ/OQ/PQ), root cause analysis, and working with vendors to deploy robust equipment and fixtures.

The candidate should hold a bachelor’s degree in engineering or related field with 8+ years in medical device manufacturing and strong analytical skills to drive uptime, cycle time improvements, and

Qualifications

Bachelor's degree in engineering or related field.
8+ years in medical device manufacturing.
ISO 13485 and FDA environments.
Root cause analysis and IQ/OQ/PQ execution.
Understanding of SPC, CPK, DOE.
Equipment, tooling, and fixture design, testing, and implementation.
Knowledge of design tools, prototyping techniques, and process evaluation methods.
Strong analytical skills and decision-making ability.

Responsibilities

Design and validate manufacturing processes, equipment, and fixtures for catheter production.
Troubleshoot production issues and implement improvements for operational efficiency.
Lead projects to enhance production metrics such as uptime, cycle time, and throughput.
Collaborate with vendors to select and develop equipment suitable for manufacturing needs.
Support scale-up efforts from development to commercialization, including process validation and transfer.