Senior Design Engineer

The Senior Design Engineer will lead the design and development of complex plastic assemblies for critical bioprocessing applications. This individual will support product development through all stages, from concept through commercialization, with a focus on building robust design practices, executing hands-on testing, and driving cross-functional collaboration. Essential Functions

• Drive the development of integrated plastic assemblies used in bioprocessing systems, with a focus on performance, manufacturability, and reliability.
• Build and maintain design guidelines and standards tailored to single-use systems in highly regulated environments.
• Lead root cause investigations and perform failure analysis for leak-proof performance and durability.
• Plan, execute, and document engineering experiments and design validations; clearly present findings and propose next steps.
• Own and continuously improve best practices for mechanical design across the organization.
• Lead transition to full SolidWorks integration across the product team; champion CAD organization and modeling standards.
• Work within a product development framework that incorporates SCRUM and daily stand-up meetings to maintain project momentum.
• Support manufacturing with design-for-manufacturing (DFM) principles and optimization of injection molding processes.
• Interface with internal and external stakeholders to ensure alignment on technical deliverables and timelines.
• Navigate and utilize PLM and ERP systems for BOM management, design releases, and engineering change control.

Do you have experience in Validation design?, * Bachelor of Science in Mechanical Engineering or related technical field, * 12+ years of experience in mechanical design engineering, with a focus on developing complex assemblies.

• 5+ years of Single-Use Technology (SUT) design experience.
• Demonstrated expertise in the design of injection-molded plastic parts and assemblies for fluid handling or leak-proof applications, including tubing, bags, and fitting integration.
• Strong understanding of Design for Manufacturing (DFM), tolerance stack-up, and process optimization principles.
• Proficient in SolidWorks, with experience managing large assemblies and transitioning teams to integrated workflows.
• Hands-on approach to problem-solving with a track record of conducting design validation testing, analyzing failures, and implementing corrective actions.
• Effective communicator with experience writing technical reports, summarizing test results, and delivering presentations with clear next steps.
• Experience participating in SCRUM, daily stand-ups, or other agile development methodologies.
• Strong ownership of design best practices and a drive to continuously improve development standards and workflows., * Experience developing products for bioprocessing, medical, or other highly regulated industries.
• Knowledge of ISO 13485, ASME BPE, or related design standards.
• Working knowledge of PLM and ERP systems such as QT9, SAP, or similar platforms.
• Prior experience establishing design guidelines or contributing to company-wide engineering standards.

About SaniSure SaniSure is a high-growth multinational manufacturer of single-use products and systems used in the production of biological drugs, including cell therapies, gene therapies, and vaccines. With operations in the U.S. and Europe, we supply global pharmaceutical and biotech companies with the critical tools they need to develop and manufacture some of today’s most innovative and life-changing medicines. As we continue to expand our product offerings and global footprint, SaniSure offers an exciting opportunity to join a nimble, customer-focused company at the forefront of the biotech industry.