Operations Lead
TITLE: Operations Lead
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: You will report to the Director of Manufacturing. The Production Line Lead plays a pivotal leadership role on the Vertex PE System manufacturing line. This position is accountable for managing daily production operations to ensure timely delivery of high-quality human-use devices while maintaining strict compliance with FDA regulations, GMP, GDP, and OSHA safety standards. The role involves end-to-end coordination of production scheduling, inventory management, and cross-functional collaboration with sterilization, quality, supply chain, and engineering teams. This position offers a unique opportunity to directly impact patient safety and product excellence by advancing manufacturing operational effectiveness and fostering a culture of continuous improvement and workplace safety.
To thrive in this role, you are a motivated and accountable leader who takes full ownership of production performance in a fast-paced, regulated manufacturing environment. You embrace a growth mindset, viewing challenges as opportunities to learn and improve, and you foster a culture of continuous development within your team. You build and maintain high-performing teams by encouraging psychological safety—creating an environment where team members feel supported to share ideas, collaborate, and take appropriate actions with confidence. Focused on operational excellence, you approach challenges as a detail-oriented, data-driven problem solver who continuously identifies and implements process improvements to enhance quality, safety, and efficiency. You work effectively across functions, including quality, supply chain, engineering, and sterilization, and confidently lead change initiatives such as transitioning to new systems and workflows. Your relentless commitment to quality and compliance, combined with resilience and dedication, enables delivery of measurable improvements and contributes meaningfully to positive patient outcomes.
This is an in-office role.
RESPONSIBILITIES
- Take full ownership of end-to-end production scheduling, including sterilization coordination, ensuring on-time delivery of all Vertex PE system products with 100% On-Time Delivery (OTD).
- Issue, control, and maintain Lot History Records (LHRs) in real time, supporting compliant and timely product release and accuracy from day one.
- Monitor and maintain finished goods and work-in-process inventory levels per production plan; proactively adjust schedules to prevent backorders and ensure inventory targets are met consistently.
- Ensure full compliance with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and OSHA safety standards—including hazard communication, machine guarding, lockout/tagout, and personal protective equipment protocols—to minimize non-conformances, production delays, and workplace injuries.
- Within the first 30 days: Rapidly assess compliance gaps in GMP, GDP, and OSHA standards and implement corrective actions, targeting measurable reduction in production incidents and non-conformances.
- Facilitate structured daily production line huddles from day 31 onwards to review performance metrics, escalate issues quickly, and foster team communication, accountability, and cross-functional alignment.
- Within 60 days: Design, implement, and sustain a visible metrics tracking board (digital or physical) that displays key production, quality, inventory, and safety KPIs to drive transparency, team accountability, and continuous improvement.
- Collaborate closely with supply chain specialists to lead the transition from LHR-based production control to Work Order management within NetSuite, championing digital transformation of operations.
- Within 90 days: Gain proficiency and oversee the implementation of Work Order processes in NetSuite; train production staff on new systems and workflows, ensuring seamless integration with quality, sterilization, and inventory management. Identify process gaps, recommend enhancements, and drive improved traceability and efficiency.
- Support quarterly validation protocols, collaborating with engineering and quality teams to troubleshoot and resolve production deviations within 48 hours, minimizing downtime and impact.
- Mentor and develop production operators, fostering a culture of continuous development, and supporting the progression of at least two operators into advanced or cross-functional roles each year, ensuring a strong succession pipeline.
QUALIFICATIONS
- High school diploma or associate degree plus at least 7 years of relevant experience in a medical device manufacturing environment.
- Strong knowledge of production process controls, cleanroom manufacturing standard operating procedures, GDP, GMP, OSHA and other quality management system requirements.
- Experience in creating and managing production schedules and forecasts using Excel and other MS office or google docs software.
- Proven experience leading production teams in regulated environments such as medical devices.
- Familiarity or willingness to learn enterprise production systems such as NetSuite for work order management.
- Excellent communication, leadership, and problem-solving skills.
- Detail-oriented, with a commitment to continuous improvement and operational excellence.
Additional Requirements
- Able to stand, sit, walk, bend, stoop, reach, lift, and carry items.
- Perform tasks that require standing and walking for long periods up to the entire shift.
- Lift, carry, push and pull in an excess of 25lb and up to 40lbs. Able to utilize “buddy System”
- Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other people.
- Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.
- Good organizational, oral and written communication skills, including ability to represent the Company to both internal and external audiences.
- Manual dexterity to operate small hand tools, measurement devices, and computer equipment.
- Must have adequate vision (corrective lenses permitted) to read schematics, blueprints, or technical documentation.
- Tolerance for working in noisy environments with machinery running (hearing protection provided).
- Will need to enter cleanroom or controlled environments and adhere to gowning protocols.
- Regular use of standard office equipment in addition to time on the production floor (e.g., dual work environment – office and shop floor).
- Must be comfortable donning PPE including safety glasses, shoes gloves, lab coats, hard hats, earmuffs, respirators or other PPE as needed.
COMPENSATION: Our job titles may span more than one career level. The starting base pay for this role is between $80,000 to $110,000 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.
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