Cell Therapy Mechanical Engineer - Consumables

Category:

Life Science

Employment Type:

Direct Hire

Reference:

BH-384977

Yoh Life Sciences
is hiring for a Cell Therapy Mechanical Engineer
for consumables in South San Francisco. The Mechanical Engineer will focus on design, prototyping, production, and verification of highly complex plastic injection-molded consumable assemblies. 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 and will require you to be onsite.

Industry:
Cell and Gene Therapy
Location:
South San Francisco
Compensation: $150,000 - $240,000
Shift:
M- F 8-5pm

Responsibilities:

• Design, develop, prototype, 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
• Prior experience 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.