Bioprocess Components Design Engineer

Microfluidics; Rohnert Park (CA); On-site; USD 110,000 - 165,000; Full time

Benefits offered by this job

Health benefits

401(k) with company match

PTO and more

Job summary

IDEX Health & Science, LLC is seeking a Bioproduction Design Engineer to design, develop, and optimize components and subsystems for upstream and downstream biopharmaceutical manufacturing, including fluidic systems and single-use assemblies, ensuring GMP compliance.

The role requires collaboration with R&D, quality, manufacturing, and customers to translate process needs into robust hardware, with emphasis on reliability, sterility, and manufacturability.

Qualifications

• 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.

Responsibilities

• Design 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 (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).
• 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

Analytical skills

Reliability & regulatory design

Cross-functional communication

Systems thinking

Documentation rigor

Education

Bachelor’s/Master’s in Mechanical/Bio/Chem Eng

Tools

SolidWorks

Job description

IDEX Health & Science, LLC is seeking a Bioproduction Design Engineer to design, develop, and optimize components and subsystems for upstream and downstream biopharmaceutical manufacturing, including fluidic systems and single-use assemblies, ensuring GMP compliance.

The role requires collaboration with R&D, quality, manufacturing, and customers to translate process needs into robust hardware, with emphasis on reliability, sterility, and manufacturability.