NPI Manufacturing Engineer

Intuitive•Blacksburg, VA

About The Position

The NPI Manufacturing Engineer contributes technical manufacturing and equipment-design expertise to a development team creating sensing platforms for minimally invasive robotic surgery. The role participates in new product development, refining electromechanical components, assemblies, process documentation, tooling, and test methods to improve product efficacy, reliability, manufacturability, and cost. The engineer develops and supports low- to mid-volume manufacturing lines and brings new products and processes from design and build through production. Responsibilities include developing and qualifying fixtures, tooling, equipment, and manufacturing processes; supporting production and process improvements; and maintaining compliance with medical-device quality systems. The role also provides technical support for failure analysis and collaborates with cross-functional teams on product-development goals, resources, budgets, and progress.

Requirements

Bachelor’s degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or a related field, or similar relevant experience.
At least 4 years of experience as a design or manufacturing engineer supporting products with significant mechanical, electromechanical, or electro-optical content.
Experience managing product and process changes.
Strong organizational skills and demonstrated ability to work on several fast-paced projects simultaneously.
Experience releasing a new product or manufacturing line through the design/build process to production.
Strong communication skills for interfacing with technicians and product development, planning, purchasing, regulatory, inspection, customer support, and clinical marketing teams.
Proven technical, analytical, and troubleshooting skills.

Nice To Haves

Successful transfer of complex manual processes to more automated processes.
Responsibility for process, equipment, or product validation or verification.
Mechanical CAD software experience, such as SolidWorks or equivalent.
Programming experience; LabVIEW is preferred.
Experience with Lean Manufacturing or Six Sigma principles.
Experience in an ISO 13485, ISO 9001, or medical-device manufacturing environment.
Experience manufacturing complex devices.
Experience with ERP systems; SAP is preferred.
Experience with line duplication or transfer.

Responsibilities

Create, maintain, and improve low- to mid-volume manufacturing lines, including bills of materials, workflows, manufacturing plans, and detailed work instructions.
Develop manufacturing lines by building prototype parts, training operators, identifying required fixtures and tooling, 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 risks using PFMEA and incorporate and validate critical manufacturing tests.
Validate and qualify manufacturing equipment and processes for production using IQ/OQ/PQ approaches.
Provide production support for sustaining and startup manufacturing lines as needed.
Test software releases before deploying them on manufacturing lines.
Implement continuous-improvement projects involving first-pass yield, cycle-time reduction, product reliability, capacity, and cost.
Provide product and process design-for-manufacturing and assembly input to improve manufacturability of new products.
Maintain connections with manufacturing-equipment suppliers and awareness of current processes and equipment.
Execute and mentor others in manufacturing process validations, process FMEAs, and other Master Validation Plan activities.
Maintain compliance with the medical-device quality system, including corrective-action closure and change-order implementation.
Provide technical support by analyzing or performing failure analysis on discrepant production components, assemblies, and field returns.
Contribute to group and individual objectives, planning, priority setting, metrics, and communication of progress.
Provide resource planning and budget estimates for product and process improvements, tooling development, and testing.