Bioprocess Component Design Engineer — Sterile Fluidics

IDEX; Rohnert Park (CA); On-site; USD 109,800 - 164,600; Full time

Benefits offered by this job

Health benefits

401(k) with company match

PTO

Job summary

IDEX is seeking a Bioproduction Design Engineer to design, develop, and optimize components and subsystems for upstream and downstream biopharmaceutical manufacturing, including fluidic systems, single-use assemblies, and process instrumentation. You will create CAD models and specifications, aiming for performance, manufacturability, cost, and scalability in GMP environments.

This role collaborates with R&D, quality, manufacturing, and customers to translate process requirements into robust

Qualifications

• Bachelor’s or Master’s degree in Mechanical, Biomedical, 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.

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 (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 (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.

Skills

CAD tools

Fluid systems

Sterilization methods

Regulatory compliance

Education

Bachelor’s or Master’s degree in Mechanical, Biomedical, Chemical Engineering

Tools

SolidWorks

Job description

IDEX is seeking a Bioproduction Design Engineer to design, develop, and optimize components and subsystems for upstream and downstream biopharmaceutical manufacturing, including fluidic systems, single-use assemblies, and process instrumentation. You will create CAD models and specifications, aiming for performance, manufacturability, cost, and scalability in GMP environments.

This role collaborates with R&D, quality, manufacturing, and customers to translate process requirements into robust