The successful candidate should have in-depth technical knowledge and sound business acumen as well as excellent communication skills to work across multiple internal teams and with customers.
• Function as an internal and external technical expert for upstream single-use bioprocessing equipment, products, processing and application methods.
• Interface directly with customers, suppliers and internal groups to resolve customer complaint investigations, drive root cause analysis and to implement design, process and supplier quality related solutions.
• Lead the design, testing and release of single-use consumable products; components, assemblies, packaging, tooling and fixtures.
• Proficient in CAD solid modeling tools; preferably SolidWorks and/or CREO.
• Leading product design to meet their intended use. Ensure performance of engineering analyses (support and review FEA, CFD analyses) to lead design decisions.
• Create and maintain DHF; detail drawings, specifications, assembly drawings and associated Bill-of-Materials, manufacturing documents, including initial assembly instructions, inspection criteria and packaging instructions.
• Verify product performance against design inputs. Write verification protocols, perform testing, analyze and interpret test data, and write and present verification reports.
• Create manufacturing documents, including initial assembly instructions, inspection specifications, component specifications, and packaging instructions.
• Release products through the ECR/ECO process.
• Lead CAPA activities and track Customer Complaint Investigation records in Trackwise System.
• Coordinate project priorities with team and Product Managers.
• Self-manage tasks. Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers.
• Maintain a safe work area.
• Bachelor’s degree in either; Mechanical Engineering, Chemical Engineering, Plastics Engineering or BioEngineering.
• 5 years relevant experience in biopharmaceutical processing, medical device or related Biotechnology field of work.
• Strong experience in plastic part design and GD&T per ASME Y14.5 standards.
• Working knowledge of plastic material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.
• Knowledge of bio-compatible material selection for sterile single-use application in bio-processing and/or medical device applications.
• Strong understanding of materials, properties, Mfg. processes, and product assembly.
• Awareness of GMP and governmental regulations related to drug manufacturing sufficient to appreciate the need for documentation accuracy.
• Ability to read and interpret professional journals and technical procedures, write test protocols and reports; communicate test analysis and results.
• Proficient with Microsoft tools; Word, Excel, Power Point, Project and Visio.
• Hands-on experience designing, prototyping and testing of components and assemblies.
• Excellent communication and influencing skills and ability to gain buy-in for initiatives.
• Master’s degree in either; Mechanical Engineering, Chemical Engineering, Plastics Engineering or BioEngineering.
• Proficient with MS Project to create Project Plans, Work Breakdown Structures (WBS) and Gantt chart schedules.
• Experience in CAE analysis tools; FEA, CFD and MoldFlow.
• Outstanding communication and writing skills for working with global manufacturing, marketing, and development teams.
• Experience in leading projects/activities to meet customer requirements.
• Familiarity with relevant regulatory and Q/A guidelines governing single-use plastic components such as Biocompatibility requirements per USP Class VI and ISO-10993.
• Six Sigma Certification (Green Belt, Black Belt) or knowledge of DFSS.
• Experience working in an Agile work environment.
• Application of Risk Management methodologies to aid in meeting commitments