Mechanical Engineer II
Period: 12 months
The focus of the Life Cycle Engineering group is to provide sustaining engineering support for single-use fluid pathway assemblies for upstream and downstream processing of biologics based on direct customer input. This position requires the application of design, engineering, root cause analysis investigation, product testing, data analysis and report writing to resolve and improve product design, process and quality issues.
Essential Responsibilities Engineering:
• Design of plastic components, assemblies, packaging, tooling and fixtures; analyze and validate tolerances, performance, cost and manufacturability. Source components.
• Supports designing products to meet their intended use. Ensure performance of engineering analyses (support / coordinate and review FEA, CFD analyses) to aid in making design decisions.
• Create detail and assembly drawings and associated Bill-of-Materials.
• 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.
• Self-manage tasks. Identify design requirements, perform risk assessments, identify required resources, estimate time and budget, and interface with peers, managers, suppliers and customers.
• Interface with a cross-functional team to resolve issues.
• Interface with customers and cross-functional groups for complaint investigations, drive root cause analysis and implement quality and design related improvements.
• Release products through the ECR/ECO process.
• Maintain safe work area.
Qualifications/Requirements • Bachelor’s degree in either; Mechanical Engineering, Plastics Engineering, or BioEngineering
• 1 to 2 years of relevant experience in Mechanical engineering, Biological Sciences, Biotechnology, medical device development or a related field
• Proficient in SolidWorks or Pro/Engineer CAD (preferably SolidWorks)
• Plastic part design and drafting GD&T per ASME Y14.5 standards
• Working experience with plastics and relevant material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.
• Basic 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
• Experience in developing DOE (Design of Experiments) test protocols and reports
• Experience in Root Cause Analysis for investigations
• Ability to write reports; communicate test analysis and results
• Familiarity with relevant regulatory and QA guidelines governing implementation and use of disposable materials and components.
• Hands-on experience designing, prototyping and testing and implementing components and designs.
• Proficient with Microsoft Word, Excel, PowerPoint
• Good communication and writing skills for working
Desired Characteristics • Six Sigma Greenbelt or Blackbelt Certification
• Proficient with Microsoft Project and Visio is desired
• Experience in FEA, CFD and MoldFlow analysis CAE tools
• Knowledge of bio-compatible material selection for sterile single-use application in bio-processing and/or medical device applications
• Experience in leading projects/activities to meet customer requirements
• Use of DFSS in designing products
• Application of risk management methodologies to aid in meeting commitments