About the role:

10x is looking for an outstanding Engineer/Senior Engineer  (Tooling, Plastic Part Designer, Assembly Engineer) to join the Process Development team. 

The candidate will be responsible for driving the consumable development, perform design optimizations, drive the assembly, develop secondary processes, to the full implementation of consumable parts required for Next Generation Sequencing chemistries and full implementation in a commercial manufacturing facility.

The position requires a broad technical understanding of consumable plastic parts assembly, injection molding, injection mold design practices, injection tooling practices, alignment of metrology with injection molding optimization, consumable part interface with instrumentation and material compatibility with NGS reagents. Demonstrated experience in the successful development and launch of plastic consumables and packaging for the medical, life science or biotech industry is required.

Individuals applying for this position must be self-starters, strategic thinkers, action driven, flexible in changing direction and methods, thrive in a fast-paced environment, excel at managing multiple priorities, succeed in communicating with all levels within the organization and provide immediate contribution.

What you will be doing:

• Detailed design optimization and development for injection molding process and equipment through risk assessment, DOE methods, scientific molding, mold flow analysis, tool optimization, tool improvement, decoupled molding and analytical testing.
• Collaborate on cross-functional teams to establish consumable process and equipment specifications and requirements, drive design, development and verification of manufacturing processes, and maintain strong alignment with the team and management through technical and project timeline reviews.
• Develop and establish plastic consumable assembly processes and QC testing.
• Conduct Design for Manufacturing (DFM) reviews for new products with internal engineers and designers, contract manufacturers, mold builders, material suppliers, and appropriate service suppliers. Lead evaluation and optimization of process and equipment, design, materials and environment to ensure product compliance.
• Handle injection molding vendor relationship, oversee DOE and other injection molding related aspects
• Drive the Component Development, Process and Equipment Verification including design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Evaluate and control process variation.
• Lead Compliance Testing to ensure product conforms to dimensional specifications and functional requirements. Maintain accurate and detailed records of testing, conduct in-depth data analysis, and clearly communicate these results through documentation and presentations.
• Evaluate project costs including capital equipment, tooling, materials, and labor.

Minimum Requirements:

• BS/MS in Mechanical Engineering, Chemical Engineering, Plastics Engineering or related field.
• 3+ years of relevant industry experience 
• Demonstrated experience in plastic component development, assembly and part optimization of injection molded plastic consumables for a life science, medical device or biotech company. 
• Demonstrated experience in optimization of assembled precision plastic parts.
• Demonstrated experience in process set-up, DOE, optimization and troubleshooting for high precision parts.
• Demonstrated experience in failure and assembly analysis for injection molded parts.
• Experience in SolidWorks, Moldflow
• Experience in Good Manufacturing Practices (GMP), ISO 9001, and ISO 13485.
• Good documentation skills and ability to write procedures and reports
• Strong collaboration and communication skills.
• Desire to be part of a rapidly evolving organization, with a compelling technology, and taking products and processes to the next level.