NPI Manufacturing Engineer

About the job

Job Description

Primary Function of the Position

Contribute your technical manufacturing and equipment design skills to a dynamic development team developing sensing platforms for minimally invasive robotic surgery. The role requires active participation in new product development teams that create and refine electro-mechanical components, assemblies, process documentation, tooling and test methods while challenging new product designs to improve efficacy, reliability, manufacturability, and cost for robotic surgical instruments.

Essential Job Duties

• Create, maintain, and improve “low to mid-volume” manufacturing lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions
• Experience developing manufacturing lines - building prototype parts, training operators, identifying fixtures/tooling needed and conducting process validation
• Design, document, procure, qualify, implement, and improve fixtures, tools, and equipment
• Define and document PMC processes for newly introduced fixtures and tools
• 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 to production status leveraging standard qualification approaches (IQ/OQ/PQ)
• Provide production support of sustaining and startup manufacturing lines as needed
• Conduct testing of software releases before deploying on manufacturing line
• Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction
• Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability of new products.
• Maintains connections with leading manufacturing equipment suppliers and is aware of latest state of the art processes and equipment
• Execute and mentor others in manufacturing process validations, process FMEAs and other elements associated with production Master Validation Plans
• Maintain compliance with medical device quality system including corrective action closure and Change Order implementation
• Provides technical support analyzing and /or performing failure analysis for discrepant production components, assemblies, and field returns
• Contribute to the establishment of group and individual objectives consistent with overall product development goals, including planning, priority setting, establishment of metrics, and effectively communicating progress
• Provide resource planning and budget estimates for product and process improvements, tooling development, and testing