Manufacturing Engineer

Description Tucson, AZ | Full-time | On-site About SynCardia Systems LLC SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (STAH), the only commercially available total artificial heart approved by both the U.S. Food and Drug Administration (FDA) and Health Canada. SynCardia is a wholly owned subsidiary of Picard Medical Inc. (NYSE: PMI) which became a publicly traded company on August 29, 2025. Why this role matters: At SynCardia our mission is to transform and save lives through life sustaining Total Artificial Heart technology. This entry level role is essential to delivering on that mission by providing mechanical engineering support for existing Total Artificial Heart System production under the guidance of senior engineers. You will help sustain and ramp manufacturing capacity, transfer processes and equipment from development into manufacturing, and drive continuous improvement across the production system in alignment with FDA ISO and international regulatory requirements. Your work directly supports product safety, reliability and performance while building a strong foundation for long term growth in medical device engineering. What you will do: Sustaining engineering & production support Provide mechanical engineering support, under the guidance of senior engineers, for existing Total Artificial Heart System production in Sustaining Engineering and manufacturing as required by business needs. Provide engineering information by responding to questions and requests from production and quality teams. Maintain product and company reputation by complying with government regulations. Learn and apply regulatory requirements as related to mechanical engineering for SynCardia products. Manufacturing projects & production ramp Assist with plans to ramp up production capacity in response to increased demand or new product introductions. Support the transfer of production processes and equipment from development to manufacturing by completing assigned tasks, documentation, and follow-up actions so that requirements are met and risks are mitigated. Support budgets, timelines, and resource tracking for manufacturing projects by preparing status updates and data for senior engineers. Participate in related company projects to build a solid working understanding of SynCardia business and quality systems. Tooling, design & process improvement Assist in designing and validating tooling that meets the requirements of the manufacturing process, including precision, repeatability, and ease of use. Assist with value stream mapping to visualize and analyze the flow of materials and information through the production system, and help identify opportunities for improvement. Help identify and eliminate waste in the manufacturing process, including defects, overproduction, waiting time, excess inventory, unnecessary motion, and unused talent. Help confirm system and product capabilities by assisting with feasibility and testing methods. Specifications, testing & documentation Assist in creating and revising product requirement specifications. Prepare product test and investigation reports by collecting, analyzing, and summarizing information, with review by senior engineers. Maintain good documentation practices for all aspects of work. Quality systems & compliance Initiate action to prevent the occurrence of nonconformities relating to the product, process and Quality System. Identify and record potential problems relating to the product, process and Quality System. Initiate, recommend or provide solutions through designated channels. Record and/or report all instances of customer feedback on product. Requirements What we are looking for:Required Bachelor’s Degree in Mechanical Engineering or Biomedical Engineering 0–2 years of relevant experience; internships, co-ops, and senior design projects count Working knowledge of SolidWorks CAD software or equivalent 3D modeling software (coursework, internship, or project experience accepted) Familiarity with Lean Six Sigma concepts and continuous improvement methods (Green Belt or coursework a plus) Exposure to manufacturing or engineering projects through internships, co-ops, or academic projects Ability to create dimensioned drawings for components & assemblies Basic knowledge of pneumatic systems Basic knowledge of mechanical measurements tools and techniques Working knowledge of geometric dimensioning and tolerancing per ASME Y14.5M (training or coursework accepted) Strong communication skills Excellent technical writing skills Good organizational skills Detail oriented Ability to handle multiple tasks simultaneously A team player / collaborative Ability to react and learn quickly in a dynamic environment Nice to have Regulated device or other regulated industry exposure preferred (medical device, aerospace, etc.) Why you will love working here: Mission-driven work with direct patient impact Collaborative, cross-functional teams Learn from senior engineers and mentors through on-the-job training and structured onboarding to promote professional growth and development. Build professional and technical knowledge by attending educational workshops, reviewing professional publications, and participating in professional societies. Work environment: Office-based role. The working environment is indoors and is seasonally heated and cooled with minimal noise levels. Prolonged periods of sitting, keyboarding/working on a computer, and the ability to move objects weighing up to 30 pounds. The position requires the ability to communicate in person, telephonically and via email. Industry: Medical equipment manufacturing Employment type: Full-time #J-18808-Ljbffr