Senior Manufacturing Engineer

Neptune Medical is an innovative and ambitious venture capital-funded Silicon Valley medical device start-up creating next-generation gastroenterology systems. We design, manufacture, and commercialize medical devices based on our proprietary Dynamic Rigidization™ technology that instantly toggles thin-walled tubes between flexible and rigid states. Pathfinder® is our first FDA-cleared device and is used in diagnostic and therapeutic GI endoscopy procedures. We are conveniently located in Burlingame, CA near the Millbrae intermodal (BART/Caltrain) station.

TITLE: Senior Manufacturing Engineer

POSITION SUMMARY:

The Senior Manufacturing Engineer is responsible for supporting volume production, product introductions, designing and validating fixturing, developing continuous improvements for assembly processes to achieve company initiatives for commercial success, value creation, and operational excellence. The role involves working closely with production, quality control, and cross-functional teams to improve operational efficiency, reduce production costs, and ensure product quality standards are met.

The ideal candidate would demonstrate the ability to meet and exceed the below requirements, would show a high level of individual responsibility as well as leadership for the team, and would act with passion and intensity in a fast-paced and collaborative medical device start-up.

Key Responsibilities:

• Process Design & Improvement:
• Identify opportunities for, lead, and implement innovative solutions for product enhancements, quality improvements, cost reduction, scaling production, and production efficiency that reduce risk and optimize production performance.
• Author and maintain manufacturing documentation, including protocols, reports, manufacturing process instructions (MPIs), lot history records (LHRs), work instructions (WIs), test methods (TMs) and, if required component/product drawings.
• Perform validation (IQ/OQ/PQ) activities and similar qualifications and generate detailed technical reports.
• Prototype fixtures using 3-D printers, lathe, drill press, band saw, etc.
• Use Lean, Six Sigma, and other process improvement methodologies to reduce waste and enhance production capabilities.
• Project Management:
• Lead engineering projects related to process improvements, new product introductions, and facility upgrades.
• Develop project timelines, allocate resources, and track progress to ensure successful project completion.
• Monitor and report on key performance indicators (KPIs) to assess project success and address any issues.
• Production Support:
• Root cause analysis to investigate yield loss and nonconformances.
• Participate in supplier selection, qualification, and NCR and CAPA efforts.
• Provide technical support to the production floor to address any issues related to machinery, tooling, or production methods.
• Troubleshoot and resolve manufacturing challenges to minimize downtime.
• Quality Control & Safety:
• Ensure all manufacturing processes meet or exceed quality standards.
• Work closely with the quality control team to resolve issues related to defects or non-conformance.
• 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 any other applicable domestic regulations.
• Champion safety programs, as applicable and enforce compliance with workplace safety standards.
• Leadership & Collaboration:
• Ensure collaboration across departments to meet production goals.
• Provide guidance and mentorship to team members as needed.
• Actively work to promote team building and morale within the department.
  

Skills and Qualifications:

• Education:
• Bachelor’s degree in Manufacturing Engineering, Industrial Engineering, Mechanical Engineering, or a related field (Master’s degree preferred).
• Experience:
• 3 years of related experience in the medical device industry in a manufacturing or operations role. 5-7 years minimum professional Engineering experience.
• Proven experience in project management and cross-functional team collaboration.
• Strong knowledge of manufacturing processes, including machining, assembly, welding, and testing.
• Technical Skills:
• Proficiency in CAD software (e.g., SolidWorks, AutoCAD) for process design and optimization.
• Familiarity with ERP systems and manufacturing software.
• Expertise in Lean, Six Sigma, and other process improvement techniques.
• Leadership Skills:
• Strong leadership, mentoring, and communication skills.
• Ability to manage multiple projects and prioritize tasks effectively.
• Strong problem-solving skills and analytical thinking.
• Other:
• Knowledge of relevant industry regulations, quality standards, and safety protocols.
• Regularly required to be independently mobile.
• Sustain periods of prolonged sitting or standing at a microscope or computer screen.
  

Our job titles may span more than one career level. The starting base salary for this role is between $140,000 and $175,000 depending on experience. The actual base pay is dependent upon many factors, such as: education, 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.

Neptune Medical 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.