Staff Manufacturing Engineer: Catheter Production Leader

Jupiter Endovascular; Menlo Park (CA); Sur place; USD 160 000 - 175 000; Plein temps

Avantages offerts par ce poste

Competitive pay with equity

Top-tier benefits (medical, dental, VZ

401(k) with employer contributions

Paid time off

Résumé du poste

Jupiter Endovascular is seeking a Staff Manufacturing Engineer to lead development and scaling of catheter manufacturing processes. You will own and improve production lines, troubleshoot issues, and drive DOEs, process validation, and equipment advancement to support commercial launch.

The role emphasizes GMP compliance, cross-functional collaboration, and hands-on fixture development, with opportunities to mentor engineers and contribute to a fast-paced startup environment.

Qualifications

• 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).
• Equipment, tooling and fixture design, testing and implementation.
• Ability to lead cross-functional teams and drive process improvements.

Responsabilités

• Design, develop, test, validate and implement processes, equipment, tooling, and fixtures for novel catheter manufacturing processes.
• Own various manufacturing processes, troubleshoot production issues and address line down situations as needed.
• Identify areas of improvement in current processes, lead execution of process improvements.
• Create and execute DOEs to determine critical parameters and define process operating windows.
• Apply critical thinking and root cause analysis techniques to solve manufacturing problems.
• Prototype fixtures and tooling using rapid prototyping techniques.
• Implement fixtures and tooling into production following relevant equipment SOPs.
• Identify and lead implementation of operational efficiency improvements.
• Identify and implement new equipment, process technologies, and solutions into production.
• Lead projects to drive achievement of operational metrics (e.g. - operational efficiency, uptime, cycle time, throughput, scrap).
• Analyze costs, identify cost improvement projects and drive achievement of cost targets.
• Develop user requirements specifications (URS) for complex mechanical and electrical equipment.
• Recommend equipment, tooling and fixturing suppliers, assist with equipment supplier selection.
• Lead next generation equipment development and qualification with equipment vendors.
• Scale up catheter manufacturing processes to meet production capacity targets.
• Drive next generation catheter process development, validation and scale up for commercialization.
• Lead execution of process validation (IQ, OQ, PQ).
• Collaborate with cross functional teams to identify and implement DFX improvements for next generation products.
• Emphasize quality and utilize a risk-driven approach to ensure compliance to risk management policies and practices and ensure Good Manufacturing Practices (GMP).
• Support company goals and objectives, policies and procedures that comply with FDA Quality System Regulations (QSR), ISO 13485, and other applicable compliance requirements.
• Develop and maintain process Failure Modes and Effects Analyses (pFMEAs) and other design controls and Quality System documentation.
• Train technicians and production assemblers on equipment set up, maintenance and calibration.
• Train and mentor junior engineers in fixture design, process controls, and process validation.
• Drive implementation of best practices to elevate the team to overcome challenges.
• Actively work to promote team building and morale within the department.

Connaissances

Medical device manufacturing

Root cause analysis

Process validation IQ-OQ-PQ

Prototyping

Data analysis

Leadership

MS Office

Statistical software

Outils

SolidWorks

Onshape

Description du poste

Jupiter Endovascular is seeking a Staff Manufacturing Engineer to lead development and scaling of catheter manufacturing processes. You will own and improve production lines, troubleshoot issues, and drive DOEs, process validation, and equipment advancement to support commercial launch.

The role emphasizes GMP compliance, cross-functional collaboration, and hands-on fixture development, with opportunities to mentor engineers and contribute to a fast-paced startup environment.