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Description
The Design Engineer – Single Use Systems and Components is responsible for the design, development, validation, and troubleshooting of single use assemblies and components used in Bio Pharmaceutical manufacturing. This role serves as a key technical resource, collaborating closely with Commercial teams, customers, and internal departments to deliver compliant, and reliable solutions aligned with regulatory and customer requirements. The Design Engineer supports customer driven product designs for contract manufacturing while contributing to cross functional initiatives, product improvements, cost reduction efforts, and issue resolution across existing product lines. All design work must be executed in accordance with current Quality Management System (QMS) requirements.
Key Job Responsibilities:
• Develop detailed designs for single use systems and components in accordance with industry standards and customer specifications.
• Collaborate with Sales and Engineering to define customer requirements, system specifications, and appropriate technical solutions.
• Evaluate customer needs and provide solutions using existing or new products.
• Troubleshoot product and system issues and deliver tailored technical resolutions.
• Resolve technical issues related to manufactured and purchased components to ensure performance, manufacturability, and customer satisfaction.
• Create assemblies and detailed drawings using CAD tools.
• Develop specifications, bills of materials, technical packets, assist in creation of assembly instructions, and work instructions for custom designs.
• Support development and execution of verification and validation protocols for new systems and components.
• The SUS Engineer is responsible for writing, executing, and concluding engineering test protocols for functional and performance testing of Single Use Systems and components in compliance with GMP.
• Perform technical evaluations and lead assembly of proofs of concept (POCs).
• Prepare technical documentation including validation reports and risk assessments.
• Ensure designs meet applicable regulatory standards (e.g., ASME BPE, FDA, ISO).
• Work closely with Manufacturing Engineering, Quality, and Production teams throughout project execution.
• Participate in customer design reviews and provide technical guidance during project delivery.
• Diagnose design and system issues, delivering timely solutions to maintain project schedules and quality.
• Identify opportunities for design optimization and cost reduction.
• Maintain strong knowledge of company products, technologies, and emerging trends in biopharmaceutical equipment and components.
• Collaborate with Manufacturing to understand production processes and apply this knowledge to system design.
• Assist Supply Chain in evaluating supplier options and sourcing components that meet customer requirements.
Requirements
Education, Skills and Experience Requirements:
• Bachelor's degree (B.S.) , or 5+ years related experience
• 5+ years in design engineering, preferably in Bio-Pharm or life sciences single use systems, with experience leading projects.
• Hands-on experience with CAD software (SolidWorks, AutoCAD, or similar).
• Strong understanding of fluid systems, pressure vessels, and sanitary design principles.
• Knowledge of validation practices and regulatory compliance (GMP, ASME BPE).
• Excellent problem-solving and communication skills.
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