Duration: 12 months
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