NPI Manufacturing Engineer

Intuitive-; Blacksburg (VA); On-site; USD 90,000 - 120,000; Full time

Job summary

Intuitive in Blacksburg, VA seeks a manufacturing engineer to contribute to the development of sensing platforms for minimally invasive robotic surgery. You will participate in cross-functional teams to refine electro-mechanical components, assemblies, tooling, and test methods aimed at cost reduction and improved manufacturability.

The role emphasizes creating scalable, reliable manufacturing processes, validating equipment, and mentoring others in process validation and DFx inputs.

Qualifications

• Experience designing and refining manufacturing lines for low-to-mid volume production.
• Familiarity with process validation and qualification (IQ/OQ/PQ).
• Ability to analyze risk via PFMEA and implement durable manufacturing improvements.

Responsibilities

• Create, maintain, and improve manufacturing lines, BOMs, workflows, and work instructions.
• Develop prototypes, train operators, and identify tooling needed; perform process validation.
• Define, document, and improve fixtures, tools, and equipment; ensure quality system compliance.

Skills

Manufacturing process design

Process validation

DFx manufacturing

Team collaboration

Problem solving

Tools

IQ/OQ/PQ protocols

Fixture/tooling design

Job description

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