Cellares
Principal Mechanical Engineer - Consumables
Cellares, South San Francisco, CA
South San Francisco, CAEngineering - Development – Mechanical Engineering /Full Time /On-siteWe are seeking an innovative and highly motivated Mechanical Engineer who will contribute significantly to developing our advanced cell therapy manufacturing platform. The primary focus of this position will be the design, prototyping, production, and verification of highly complex plastic injection-molded consumable assemblies. As a Principal Mechanical Engineer (consumables), you will be responsible for component selection, design tasks, manufacturing coordination, sterilization coordination, and initial quality assurance efforts of both individual components, and finished assemblies. Additionally, you will be required to provide in-depth analysis and CAD data to help guide important decisions during design reviews. This is a multidisciplinary role, and this individual will further interface across many parts of the company to develop novel products used in cell therapy and gene therapy. The successful candidate will be experienced in plastic injection molding, material selection, and component selection for complex biomedical consumable device design. This is a hands-on position.Candidates should enjoy working in a fast-paced, mission-driven environment and be prepared to tackle a broad selection of challenges as the company grows.ResponsibilitiesResponsible for the design, development, prototyping, and volume manufacturing of complex injection molded assemblies and high-precision mechanical components & assembliesSpecifying injection molding tooling with state-of-the-art capabilities: Variotherm, vacuum assist, hot runners, etcDesign and development of manufacturing test fixtures as requiredIdentify & interface with key component vendors (suppliers of tubing, valves, etc, that may be integrated into our consumable design)Interface with R&D systems & mechanical engineering teams to negotiate designs that meet product requirements & are feasible to manufacture economicallyConduct design reviews and present fresh ideas, new technologies, and creative solutions to design problemsShow proof of concept through rapid prototypingWork closely with the scientific team through the creation of verification/validation protocols (IQ, OQ, PQ) as well as successful execution, data generation, reporting, and documentationWork with external companies as needed to outsource injection molding activities and manage the vendors through all phases of the projects, including user requirements, RFQ, vendor selection, and concept & design, followed by verification/validationWork with external companies as needed to outsource consumable assembly and sterilization activities through all phases of the project(s)Create comprehensive work instructions and manufacturing SOPs as needed Requirements15+ years of hands-on experience with plastic injection molding, including but not limited to component design, design optimization, mold design5+ years of experience designing and building one-time-use tubing sets or consumables for the medical or biotech industryIn-depth knowledge of materials science/plastics properties and metrology techniquesExperience with drafting engineering drawings, BOMs, and product specificationsGood understanding of DFM and lean manufacturingExcellent verbal, written, presentation, and interpersonal skills. Strong analytical and problem-solving skillsPrior experience with FDA regulations and ISO, cGMP, QMS standards & with USP class VI materialsKnowledge and hands-on experience with machine shop toolsStrong proficiency with SolidWorks CAD toolsWork history with several successful iterations of molded components transferred successfully to volume manufacturingWorking knowledge of manufacturing techniques, including machining, injection molding, and bonding of consumables (ultrasonic welding, laser welding) for biotech componentsDesire to be part of a rapidly evolving organization with compelling technology, and ready to take products and processes to the next levelSelf-awareness, integrity, authenticity, and a growth mindset$150,000 - $240,000 a yearCellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Free EV Charging, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.