Job Description
Job Description
TITLE: Staff Manufacturing Engineer
COMPANY SUMMARY: 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. We have raised capital from a diversified investor base, including venture capital, private equity, and corporate strategic investors.
POSITION SUMMARY: 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 advise the manufacturing/ process 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.
ROLES AND RESPONSIBILITIES
- Design, develop, test, validate and implement processes, equipment, tooling, and fixtures for novel catheter manufacturing processes.
- Identify areas of improvement in current processes, lead creation and execution of process improvement plans.
- Create and execute DOEs to determine critical parameters and define process windows.
- Prototype fixtures and tooling using 3-D printers, lathe, drill press, band saw, etc.
- Implement fixtures into production following relevant equipment SOPs.
- Own various process steps as an SME, troubleshoot production issues and address line down situations as needed.
- Identify and lead implementation of process and operational efficiency improvements.
- Identify and implement new equipment, process technologies, and solutions into production.
- Define key performance indicators (KPIs) and lead projects to drive KPI achievement. (e.g. - operational efficiency, uptime, cycle time, throughput, scrap)
- Analyze costs, identify cost improvement projects and drive achievement of cost targets.
- Lead identification and implementation of Lean Six Sigma and 6S improvements.
- Develop user requirements specifications (URS) for complex equipment.
- Lead next generation equipment development and qualification with equipment vendors.
- Recommend equipment, tooling and fixturing suppliers, assist with supplier selection and technical development.
- Assist with supplier process validation of components and sub-assemblies
- Scale up catheter manufacturing processes to meet production capacity targets
- Drive next generation catheter process development, validation and scale up for commercialization.
- Lead validation activities (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.
REQUIRED QUALIFICATIONS
- Required minimum education: Bachelor's degree in Engineering
- Required minimum experience: 8 years in medical device manufacturing
- Catheter manufacturing and assembly experience strongly preferred
- Experience with root cause analysis, process validations (IQ-OQ-PQ), Lean Six Sigma, 6S
- 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 sound decision-making and good judgment consistent with a senior 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.
- Equipment, tooling and fixture design a plus.
- Languages: Full professional proficiency in verbal and written English.
COMPENSATION: Our job titles may span more than one career level. The starting base pay for this role is between $150,000-$175,000. 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.