Sustaining Engineer - Medical Device Process & Supplier

Jupiter Endovascular, Inc.; Menlo Park (CA); On-site; USD 90,000 - 105,000; Full time

Benefits offered by this job

Equity opportunities

401(k) with employer contributions

Competitive pay

Medical, dental, vision

Job summary

Jupiter Endovascular in Menlo Park, CA seeks a Sustaining Engineer to support design, process and quality improvements for Class II sterile catheter-based products. You will manage sustaining projects, perform RCA, and collaborate across Quality, Manufacturing, and Operations to ensure supply chain robustness.

The role is in-office in a fast-paced startup environment with opportunities for growth and equity. A strong foundation in engineering and hands-on problem solving is essential.

Qualifications

• 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.

Responsibilities

• Continuous improvement of products, processes and suppliers.
• Lead and execute implementation of sustaining projects following change controls 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.

Skills

Root cause analysis

Process validation

Supplier quality

Communication skills

Independent work

Continuous improvement

Education

Bachelor’s degree in engineering or related field

Job description

Jupiter Endovascular in Menlo Park, CA seeks a Sustaining Engineer to support design, process and quality improvements for Class II sterile catheter-based products. You will manage sustaining projects, perform RCA, and collaborate across Quality, Manufacturing, and Operations to ensure supply chain robustness.

The role is in-office in a fast-paced startup environment with opportunities for growth and equity. A strong foundation in engineering and hands-on problem solving is essential.