Principal Mechanical Engineer - Consumables

We 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.

• Responsible for the design, development, prototyping, and volume manufacturing of complex injection molded assemblies and high-precision mechanical components & assemblies
• Specifying injection molding tooling with state-of-the-art capabilities: Variotherm, vacuum assist, hot runners, etc.
• Design and development of manufacturing test fixtures as required
• Identify & 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 economically
• Conduct design reviews and present fresh ideas, new technologies, and creative solutions to design problems
• Show proof of concept through rapid prototyping
• Work closely with the scientific team through the creation of verification/validation protocols (IQ, OQ, PQ) as well as successful execution, data generation, reporting, and documentation
• Work 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/validation
• Work 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

• 15+ years of hands-on experience with plastic injection molding, including but not limited to component design, design optimization, mold design
• 5+ years of experience designing and building one-time-use tubing sets or consumables for the medical or biotech industry
• In-depth knowledge of materials science/plastics properties and metrology techniques
• Experience with drafting engineering drawings, BOMs, and product specifications
• Good understanding of DFM and lean manufacturing
• Excellent verbal, written, presentation, and interpersonal skills. Strong analytical and problem-solving skills
• Prior experience with FDA regulations and ISO, cGMP, QMS standards & with USP class VI materials
• Knowledge and hands-on experience with machine shop tools
• Strong proficiency with SolidWorks CAD tools
• Work history with several successful iterations of molded components transferred successfully to volume manufacturing
• Working knowledge of manufacturing techniques, including machining, injection molding, and bonding of consumables (ultrasonic welding, laser welding) for biotech components
• Desire to be part of a rapidly evolving organization with compelling technology, and ready to take products and processes to the next level
• Self-awareness, integrity, authenticity, and a growth mindset