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Jupiter Endovascular

Develops and sells endovascular cardiovascular devices

Staff Manufacturing Engineer

Biomedical Engineering & Medical DevicesConfirmed live in the last 24 hours
Full-timeMenlo Park, CA, USAIn-person

About the Job

Requirements

  • A bachelor's degree in engineering.
  • At least 8 years of experience in medical device manufacturing.
  • Experience with root cause analysis and process validations (IQ, OQ, PQ).
  • Experience designing, testing, and implementing equipment, tooling, and fixtures.
  • A proven track record of using varied design tools, prototyping techniques, and evaluation methods to develop, test, and demonstrate new concepts.
  • Ability to apply critical thinking, data analysis, sound decision-making, and good judgment consistent with a Staff-level position.
  • Ability to work independently in a fast-paced environment while managing changing priorities.
  • Working knowledge of applicable Quality System and compliance requirements.
  • Proficiency in Microsoft Office suites.
  • Proficiency with statistics, including process capability, CPK, DOE, and SPC, and statistical analysis software.
  • Full professional proficiency in verbal and written English.

Responsibilities

  • Design, develop, test, validate, and implement processes, equipment, tooling, and fixtures for novel catheter manufacturing processes.
  • Own manufacturing processes, troubleshoot production issues, and address line-down situations as needed.
  • Identify areas for improvement in current processes and 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 achieve operational metrics, including operational efficiency, uptime, cycle time, throughput, and 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 and 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 use a risk-driven approach to ensure compliance with risk-management policies and practices and Good Manufacturing Practices (GMP).
  • Support company goals, 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), design controls, and Quality System documentation.
  • Train technicians and production assemblers on equipment setup, maintenance, and calibration.
  • Train and mentor junior engineers in fixture design, process controls, and process validation.
  • Drive implementation of best practices to help the team overcome challenges.
  • Actively promote team building and morale within the department.

Desired Qualifications

  • Experience with catheter manufacturing equipment is strongly preferred.
  • Proficiency in SolidWorks or Onshape is a plus.

About the Company

Jupiter Endovascular

Develops and sells endovascular cardiovascular devices

Jupiter Endovascular develops and sells advanced endovascular devices to improve cardiovascular health, serving hospitals and cardiovascular clinics worldwide. The devices are catheter-based tools developed, regulatory-cleared, and clinically validated, used in procedures to treat heart and blood vessel conditions, with revenue from direct device sales and partnerships with other medical firms. It distinguishes itself through a heavy emphasis on clinical affairs and product management, a global market presence, and strategic collaborations to expand reach while prioritizing safety and proven efficacy. The company's goal is to improve patient cardiovascular outcomes by delivering reliable, clinically validated endovascular solutions to healthcare providers worldwide.

Company size
51-200
Company stage
Series B
Total funding
$40M
Headquarters
Menlo Park, CA
Founded
2024

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