Sustaining Engineer II Menlo Park, CA

Title: Sustaining Engineer II

Imagine a world where you could bring the precision and control of surgery to catheter-based therapies. For decades, endovascular procedures have been constrained by the technological limitations of catheters that lose stability and control within the anatomy. We have created a new class of therapies to overcome these constraints by using Endoportal Control to mimic the precision and control of direct surgical access, while maintaining the minimally invasive profile of an endovascular intervention.

Our vision is big, spanning the breadth of cardiovascular disease where we see compelling opportunities to reimagine therapies for millions of patients. Jupiter Endovascular is a medical technology startup located in the San Francisco Bay Area, led by a team of successful medical device entrepreneurs. We have big ambitions, with a culture built on innovation, teamwork, and speed.

The Sustaining Engineer II will be a critical team member within Product Development at Jupiter with a focus on supporting ongoing design, process and quality improvements, supplier development, and supplier capacity expansions for Class II single-use sterile catheter-based products. The role will support component non-conformances, root cause analysis, testing, qualification and supplier capacity ramp up for critical components, sub-assemblies and processes related to the pulmonary embolectomy aspiration system in support of full commercial launch.

This individual will work cross-functionally with Quality, Manufacturing, and Operations within an FDA-regulated medical device environment and reports directly to an Engineering Manager.

• Continuous improvement of products, processes and suppliers.
• Lead and execute implementation of sustaining projects following change control procedures.
• Manage internal and external communication for sustaining projects.
• Perform verification and validation testing as required to implement changes.
• Collaborate with Operations and Product Development to identify supply chain risks.
• Perform root cause analysis investigations of component failures and non-conformances.
• Collaborate with suppliers and internal teams to implement corrective actions.
• Support resolution of customer complaint investigations related to component issues.
• Perform statistical analysis of data and recommend supplier corrective actions based on process monitoring and statistical process controls.
• Collaborate with Quality and Product Development to define component inspection requirements.
• Collaborate with Product Development to recommend improvements to next generation products and processes based on RCA investigations.
• Support supplier development, qualification, and capacity scale up to meet forecasted demand.
• Collaborate with suppliers to create and execute validation plans.
• Identify, develop and qualify new suppliers as required to mitigate supply chain risks.
• Create and maintain QMS documentation related to sustaining projects.
• Recommend improvements to SOPs and work processes.
• Work effectively within the confines of a regulated, quality system driven, FDA monitored medical device environment.

• Required minimum education:
  
  Bachelor’s degree in engineering or related field.
• Required minimum experience: 3 years in a related role.
• Medical Device experience preferred.
• Experience with root cause analysis.
• Experience with process validation (IQ, OQ, PQ) preferred.
• Experience with supplier quality a plus.
• Strong communication and presentation skills.
• A strong desire to lead continuous improvement initiatives.
• Ability to work independently in a fast-paced environment while managing changing priorities.
• A demonstrated desire to work in a small medical device startup.
• A willingness to work hard, with a driven outlook and with a strong desire to succeed as an engineer, as a team, and as a company.

The starting base pay for this role is between $90,000-$105,000. The actual base pay is dependent upon many factors, such as training, transferable skills, work experience, business needs, and location. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits, and 401(k) with matching.

Jupiter Endovascular provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.