Job Description :
Title: Project Engineer , Hardware Product Care
Location Boston,MA
Education: Bachelor's degree in either Electrical Engineering, Electronic or Instrumentation and controls Engineering.
Required Experience/Skills:
Minimum 2 years of relevant experience in either Life Sciences, Bioprocessing, Pharmaceutical, Biotechnology, medical device development or a related field.
Experience in supporting projects/activities to meet customer requirements.
Familiar with industrial panel design, electro-mechanical components and assemblies such as; motors, pumps, motion controls, temperature controls and sensors.
Experience in Risk Management methodologies, Root Cause Analysis and CAPA activities.
Experience in selection and Design of PLC, Motor drives, Power supplies, I/O devices, Sensors, I/O Panels, and proven expertise in integrating these devices to the system.
Expertise in creation/modification of electrical schematics for wiring sensors, transmitters, devices, etc. in I/O cabinets.
Experience with 2D electrical computer aided design like AutoCAD Electrical/3D tools like E-Plan.
Experience in design of I/O cabinets for Automation panel, Components selection, layout design of cable/wire routings for I/O cabinets etc.
Hands on experience in design calculations-Power, Thermal etc. Critical components selection and evaluation for system level design.
Demonstrated ability to design industrial automation hardware systems to meet regulatory standards (UL, IEC, NFPA, CE Marking, LVD)
Experience in working with Engineering Change Orders (ECO) & Engineering Change Requests (ECR). Full knowledge of PLM or Equivalent. Working knowledge\?
Responsibilities:
Interface directly with customers, suppliers, and internal teams to resolve customer complaint investigations, drive root cause analysis to implement design, process and supplier quality related solutions.
Support the design, testing and release of Upstream Bioprocessing hardware products, components, assemblies, packaging, tooling and fixtures. Analyse and validate designs per user requirements to meet performance, cost, compliance and manufacturability targets.
Create and maintain DHF; detail drawings, schematics, 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, write and present verification reports.
Analyze and resolve quality issues, initiating sample build and lab testing, evaluating test samples, introduction and follow up of design changes in manufacturing.
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 complete Customer Complaint Investigations.
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.
             

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