Manufacturing Engineer in Menlo Park

Energy Jobline ZR; Menlo Park (CA); On-site; USD 120,000 - 170,000; Full time

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.

Skills

Root cause analysis

Process validation

Analytical skills

Decision making

Education

Bachelor's degree in engineering or related field

8+ years in medical device manufacturing

Job description

Job DescriptionJob Description

Qualifications:

• Bachelor’s degree in engineering or related field
• Experience of at least 8 years in medical device manufacturing
• ISO 13485 and FDA environment
• Ability to perform root cause analysis and execute process validations (IQ, OQ, PQ)
• Understanding of statistical analysis (SPC, CPK, DOE)
• Skilled in 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