Intuitive
Healthcare
ManufacturingEngineer
“Manufacturing Engineer at Intuitive. Skills: technical manufacturing, equipment design, electro-mechanical components, assemblies, process documentation, tooling, test methods, validation, qualification. Create, maintain and improve “low to mid-volume” manufacturing lines. specifying and/or refining BOMs, work flow processes, manufacturing plan and detailed work instructions.”
What You'll Achieve.
improve efficacy, reliability, manufacturability and cost for robotic surgical instruments.; improve outcomes around the world.; first pass yield; cycle time reduction; product reliability; capacity enhancement; cost reduction.
Industry & Context.
sound decisions when faced with the time pressures and incomplete information typical of new product development and early stage manufacturing environments.
proof of vaccination against certain diseases including COVID-19 may be required, subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.
What They're Looking For.
Must Have
Minimum BS/MS degree in Mechanical Engineering, Mechatronics, Electrical Engineering or Industrial Systems Engineering., Minimum 3 years of experience as design or manufacturing engineer supporting product with significant mechanical, electromechanical, or electro optical content., Must possess communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams., Prior responsibility for process, equipment or product validation/verification.
Nice to Have
Prior experience with complex device manufacturing is a plus, Experience in new product introduction/development desirable, CAD experience preferred, Previous experience with ERP systems (preferred SAP) is a plus, Programming skills is a plus, Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus
What You'll Do.
maintain and improve “low to mid-volume” manufacturing lines
specifying and/or refining BOMs
manufacturing plan and detailed work instructions.
Analyze manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/PQ).
Provide production support of sustaining and startup manufacturing lines.
Conduct testing of software releases before deploying on manufacturing line
Identify and implement continuous improvement projects with respect to first pass yield
capacity enhancement and cost reduction.
Provide product and process Design for Manufacturability and Design for Assembly input to enhance manufacturability of new products.
Take responsibility for maintaining compliance with medical device quality system including corrective action closure
discrepant material dispositions and ECO implementation.
Provides technical support analyzing and /or performing failure analysis for discrepant production components
assemblies and field returns.
Maintain all documentation associated with the manufacturing line.
Conduct SAP transactions relevant to manufacturing operations.
Provide technician training and oversee specified manufacturing stations to ensure quality.
How You'll Work.
Team & Collaboration
active participation in new product development teams; coordinate their efforts with the development and manufacturing teams; interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.
Communication Scope
communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.
Process & Methodology
report progress and milestones relative to the overall project
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