GEHC - Mechanical Engineer III
Description:max BR - BR/hourmax markup - 48%*Potential for temp-perm - Please be sure candidates are able to work in the US without sponsorship*Open to non local candidates if they will relocate at their own expenseProject Engineer Contractor, Life Cycle EngineeringRole SummaryThe GE Healthcare is looking for an experienced Project Engineer to support our Product Care Life Cycle Engineering team.The Project Engineer position is located in the Westborough R&D Life Cycle Engineering group within the Biotechnology business area in GE Healthcare Life Sciences. The primary focus of this position is to provide sustaining engineering support for Xcellerex Disposable Reactors used in Upstream and Downstream processing of biologics based on direct customer input. This position requires the application of design, investigation root cause analysis, product testing, data analysis and report writing to resolve customer complaints / product issues and implement existing product design improvements, all while working in a cross-functional team environment.Essential Responsibilities• This work would include mechanical engineering competencies & skills for all products in the install base.• 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.• Work in an acquisition environment and support business transfer activities• Execute the design, testing and release Xcellerex hardware products; components, assemblies, packaging, tooling and fixtures. Analyze and validate designs (support and review FEA, CFD analyses) per user requirements to meet performance, cost, compliance and manufacturability targets.• Create and maintain design history file; detail drawings, specifications, assembly drawings and associated Bill-of-Materials, manufacturing documents, including initial assembly instructions, inspection criteria and packaging instructions while following good documentation practices.• 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.• Experience with change control processes and ability to release products through the ECR/ECO process.• Support with 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.Qualifications/Requirements• Bachelor's degree in Mechanical Engineering or Biomedical Engineering with a mechanical focus• Defining and executing component design verification• Minimum of 2 years relevant experience• Proficient in CAD solid modeling tools; preferably SolidWorks and/or CREO. Stay current and develop competence required for the job• 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.• Experience with Microsoft tools; Word, Excel, Power Point, Project and Visio.• Hands-on experience designing, prototyping and testing of components and assemblies.• Ability to work in global teams with good communication and influencing skills and ability to gain buy-in for initiatives.Desired• Master's degree in Mechanical Engineering• Hands-on experience with BioProcessing equipment and application methods.• 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.• Experience working in an Agile work environment.• Application of Risk Management methodologies to aid in meeting commitmentsQualification Rating Must Have HealthcareDriving record verification?NoEducation verification?NoGEHC Magnetic Resonance Employee Questionnaire for Metallic Foreign Body and Electronic Devices?