Design Engineer - Bioprocess Components

IDEX Corporation•Rohnert Park, CA

1d•$109,800 - $164,600•Onsite

About The Position

The Bioproduction Design Engineer is responsible for the design, development, and optimization of components and subsystems used in upstream and downstream biopharmaceutical manufacturing, including fluidic systems, single-use assemblies, and process instrumentation. This role bridges product development and bioproprocess application, ensuring designs meet performance, regulatory, and manufacturability requirements for use in GMP environments. The position requires strong cross-functional collaboration with R&D, quality, manufacturing, and customers to translate process requirements into robust and scalable hardware solutions.

Requirements

Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field
3–8+ years in product design, preferably in bioprocessing, medical devices, or fluidics
Proficiency in CAD tools (e.g., SolidWorks)
Understanding of fluid systems, sensors, materials, and sterilization methods
Strong analytical and problem-solving skills (design validation, data interpretation)
Ability to design for reliability, sterility, and regulatory compliance
Cross-functional communication and customer-facing technical skills
Systems-level thinking (component-to-system integration)
Attention to detail and documentation rigor

Nice To Haves

Experience with single-use technologies, sterile fluid paths, or bioprocess equipment
Familiarity with extractables/leachables, biocompatibility, and material selection
Knowledge of manufacturing processes (injection molding, extrusion, assembly)
Experience with sensor integration (e.g., pressure, flow, pH, conductivity)

Responsibilities

Design and develop bioproduction components such as sensors, tubing assemblies, connectors, manifolds, filters, and related flow-path devices
Create detailed CAD models, drawings, and specifications for new products and revisions
Optimize designs for performance, manufacturability, cost, and scalability
Apply engineering principles to optimize fluid control, mass transfer, and material compatibility in bioproduction systems
Translate bioprocess requirements (e.g., sterility, flow rates, shear sensitivity, extractables/leachables) into component designs
Integrate components into larger systems such as single-use assemblies, bioreactors, or downstream skids
Support customer-specific design adaptations and custom configurations
Collaboratively develop test plans for performance validation (e.g., flow, pressure, integrity, sterility assurance)
Analyze data to validate designs and identify opportunities for improvement
Perform root cause analysis and troubleshooting of design and field issues
Ensure designs comply with biopharma standards (e.g., GMP, FDA, ISO, USP guidelines)
Support documentation for design controls, risk assessments (FMEA), and validation protocols
Contribute to quality systems including change control and CAPA
Work closely with bioprocess engineers, scientists, and manufacturing teams to support product design and introduction
Collaborate with Supply Chain on materials, components, and vendor requirements
Participate in design reviews and technical risk assessments