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 (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

Regulatory & Quality Compliance

• 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

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 (e.g., 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. We anticipate hiring this role at the midpoint of the salary range. This position may be eligible for performance based bonus plan.

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

Benefits Package

Our comprehensive U.S. benefit offerings include: Health benefits, 401(k) retirement savings program with company match, PTO, and more. More information on our benefits and rewards can be found on our career page: https://www.idexcorp.com/careers/our-benefits-and-rewards/

This posting is for an existing vacancy.

Artificial intelligence is not used to screen, assess or select applicants.