Design Engineer - Bioprocess Components

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

Position Summary

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 bioprocess 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.

Key Responsibilities

• Product Design & Development: 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.
• System Integration & Application Engineering: 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.
• Testing, Validation & Analysis: 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.
• Regulatory & Quality Compliance: 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.
• Cross‑Functional Collaboration: 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.

Required 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.

Preferred Experience

• 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 (pressure, flow, pH, conductivity).

Key Skills & Competencies

• 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.

Total Rewards

The compensation range for this position is $109,800.00 - $164,600.00, depending on experience. This position may be eligible for a performance‑based bonus plan.

Benefits Package

Our comprehensive U.S. benefit offerings include health benefits, a 401(k) retirement savings program with company match, PTO, and more.

Equal Opportunity Employer

Idex is an Equal Opportunity Employer. Idex gives consideration for employment to qualified applicants without regard to race, color, religion, creed, genetic information, sex, sexual orientation, gender identity or expression, marital status, age, national origin, disability, protected veteran status, or any other consideration or protected category made unlawful by federal, state or local laws. Applicants with a disability who require a reasonable accommodation to complete any part of the application process can contact our Talent Acquisition Team at [e-mail] for assistance with an accommodation. Please contact [e-mail] for any accommodation needs. We will determine an alternate way for you to apply. This posting is for an existing vacancy.