Staff Manufacturing Engineer
About The Position
Join a team that’s redefining what’s possible in cardiovascular treatment. At Jupiter Endovascular, we’re revolutionizing catheter-based therapies by bringing the precision and control of surgery to minimally minimally invasive procedures. For decades, catheters have remained largely unchanged—rigid, unstable, and difficult to maneuver through the body’s winding anatomy. We’ve developed a transforming fixation technology that navigates flexibly through the vascular system, then locks into place to deliver treatment with surgical-like stability and control. Our device solves one of the longest-standing challenges in endovascular procedures, empowering physicians and improving outcomes for millions of patients living with cardiovascular disease. We’re entering an exciting new phase—scaling up production, expanding our team, and preparing for commercial launch. Founded and headquartered in Menlo Park, California, Jupiter Endovascular is led by a proven team of medical device entrepreneurs and backed by top-tier investors across venture capital, private equity, and strategic partners. We’ve built a fast-paced, collaborative culture grounded in innovation, teamwork, and purpose. Every role at Jupiter directly contributes to our mission: saving lives by advancing the future of endovascular therapy. The Staff Manufacturing Engineer will be a core team member of our growing manufacturing/process development team leading early development of novel manufacturing processes and paving the way for our scale up to commercial launch. Additionally, the engineer will oversee, troubleshoot, and improve existing production processes. This role will be involved in multiple production lines and support the manufacturing engineering and operations teams. The ideal candidate would act with passion and intensity in a medical device start-up that is fast-paced and collaborative and would display the ability to perform the requirements outlined below. For the right person, this position will be a tremendously exciting and career-defining opportunity, making core contributions to a new paradigm of catheter-based interventions. This is an in-office role.
Requirements
- 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, process validations (IQ-OQ-PQ)
- Equipment, tooling and fixture design, testing and implementation.
- Proven track record of using a variety of design tools, prototyping techniques, and evaluation methods to develop, test, and demonstrate the value of new concepts.
- Ability to exercise critical thinking, data analysis, sound decision-making and good judgment consistent with a Staff level position.
- An inventive and creative problem-solving aptitude balanced with discipline and detail-orientation.
- A willingness to work hard, with a driven outlook and with a strong desire to succeed as both an individual and as a core team member.
- Ability to work independently in a fast-paced environment while managing changing priorities.
- Working knowledge of applicable Quality System and compliance requirements.
- Proficiency in MS Office suites.
- Proficient with statistics (process capability, CPK, DOE, SPC) and statistical analysis software
- Proficiency in Solidworks or Onshape a plus.
- Languages: 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 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.
Benefits
- performance incentives
- equity opportunities
- comprehensive, top of the market medical, dental, and vision coverage
- top tier 401(k) with a best in-class plan design which includes strong employer contributions
- short and long-term disability
- life insurance
- commuter benefits
- wellness support
- healthy paid time off policy
- company holidays
- company-provided lunches
- Thursday socials
- monthly potlucks
- company events
- volunteer opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Senior
