NPI Manufacturing Engineer

Intuitive•Sunnyvale, CA

About The Position

This New Product Introduction Manufacturing Engineer (NPI Engineer) position reports to the Manufacturing Engineering Manager for Da Vinci Single Port Surgical System’s Instrument products. In this position, the NPI Engineer utilizes their knowledge to assist with the implementation of new assembly and test equipment along with assembly process improvements. Their primary focus is to develop assembly and test processes, confirm engineering requirements, consider process risks, and identify solutions to guide development. They focus on opportunities for poka-yoke, DfX, semi-automated and automated solutions, and design for assembly opportunities, specifically with an emphasis on safety, reliability, serviceability, manufacturability, and cost. In addition to process improvements, they also help respond to, escalate, and resolve emergent issues on the manufacturing line.

Requirements

BS Mechanical, Biomedical, or Manufacturing Engineering.
Project participation and strong communication skills to drive assembly equipment, fixturing, and tooling design from development through implementation.
Solid modeling/CAD experience (SolidWorks preferred).
An introductory understanding of manufacturing processes including injection molding, machining, stamping, laser welding, design of experiments, and capability analysis.
An introductory knowledge of Minitab, Excel, or other statistical analysis software and methods.
Skills in prototyping, tooling development, process engineering, and troubleshooting.
Comfortable interacting with engineers, management, technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers.
Independent problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments.
Proficient organization, follow-up, and documentation skills.
References who will validate you as a team player, self-starter, and possessing a can-do attitude!

Nice To Haves

MSME, MSBMED, or MSMfgE and experience is as a design or manufacturing engineer preferred.
Manual assembly manufacturing process development experience.
Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus.
Experience implementing changes to new or established products preferred.
Machine tool experience a plus.
Medical device experience preferred but not required.

Responsibilities

Competency in mechanical, electrical, materials, and software engineering fundamentals with preferred experience in engineering design and manufacturing.
Knowledge of equipment and methods to develop and implement assembly and test processes of complex medical devices.
Ability to work with support teams on software, algorithms, electronic aspects of the device, and human interface needs.
Assists with identification of opportunities to enhance manufacturability and product cost (DfX) and provides input to Product Development Engineering.
Assists with the identification and assessment of potential process risks and mitigations and provides input to the development of process FMEA and other quality records.
Assists with validation, qualification, and documentation of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ/PPQ).
Provides technical support for failure analysis of discrepant production components, assemblies, and field returns.
Collaborates with a cross-functional team to identify root cause, determine mitigations, and drive implementation using tools such as 8D, DMAIC, 5-Why, Fishbones, etc.