Staff Manufacturing Engineer: Catheter Scale-Up & Process Improvement

Jupiter Endovascular; Palo Alto (CA); On-site; USD 160,000 - 175,000; Full time

Job summary

Jupiter Endovascular in California is seeking a Staff Manufacturing Engineer to lead early development of novel catheter manufacturing processes and oversee ongoing production improvements. The role is in-office, cross-functional, and focuses on scale-up to commercial launch with a strong emphasis on GMP/QSR compliance.

The ideal candidate has at least 8 years in medical device manufacturing, experience with catheter equipment, and proven skills in root cause analysis, DOEs, and process

Qualifications

• Bachelor's degree in engineering.
• Minimum 8 years of experience in medical device manufacturing.
• Experience with catheter manufacturing equipment strongly preferred.
• Experience with root cause analysis and process validations (IQ-OQ-PQ).
• Proficiency with design tools, prototyping techniques, and evaluation methods.
• Ability to exercise critical thinking, data analysis and sound judgment.
• Willingness to work hard and contribute as a core team member.
• Fluency in professional English.

Responsibilities

• Design, develop, test, validate and implement processes, equipment, tooling, and fixtures for catheter manufacturing.
• Own various manufacturing processes, troubleshoot production issues and address line down situations.
• Identify improvements and lead execution of process optimizations.
• Create and execute DOEs to determine critical parameters and operating windows.
• Apply root cause analysis to solve manufacturing problems.
• Prototype fixtures and tooling using rapid prototyping techniques.
• Scale up catheter manufacturing processes to meet production capacity targets.
• Lead projects to achieve key operational metrics such as uptime, cycle time and throughput.
• Develop URS for complex equipment and assist with supplier selection.
• Train technicians and junior engineers on equipment setup, controls and validation.

Skills

Root cause analysis

Data analysis

Critical thinking

Process validations (IQ-OQ-PQ)

Education

Bachelor's degree in engineering

Tools

Solidworks

Onshape

MS Office

Statistical analysis software

Job description

Jupiter Endovascular in California is seeking a Staff Manufacturing Engineer to lead early development of novel catheter manufacturing processes and oversee ongoing production improvements. The role is in-office, cross-functional, and focuses on scale-up to commercial launch with a strong emphasis on GMP/QSR compliance.

The ideal candidate has at least 8 years in medical device manufacturing, experience with catheter equipment, and proven skills in root cause analysis, DOEs, and process