Senior NPI Manufacturing Engineer

Intuitive•Sunnyvale, CA

About The Position

Develop, validate, and continuously improve processes and tools for low-volume manufacturing and testing of complex robotic capital equipment used in minimally invasive, robotically assisted laparoscopy. The role participates in sustaining and new product development teams and supports manufacturing lines. It develops manufacturing equipment and refines electromechanical components, assemblies, process documentation, tooling, and test methods. The engineer also challenges product designs to improve efficacy, reliability, manufacturability, and cost for robotic surgical equipment.

Requirements

Minimum 7 years in a manufacturing- or design-related role, or 5 years with a master's degree in a technical discipline.
Mechanical design or tool design experience.
Strong 3D CAD and solid-modeling skills; SolidWorks preferred.
Strong written and verbal communication skills, including the ability to engage with technicians, production management, product development, planning, purchasing, regulatory, inspection, customer support, and clinical marketing organizations.
Experience with ALM and PLM tools for engineering change orders and risk management.
A continuous-improvement mindset.
Knowledge of process controls, including Six Sigma and CPK.
Technical problem-solving skills, including root-cause identification and corrective action using methods such as Fishbone and 8D analysis.
Ability to use statistical methods, including Cpk, ANOVA, and Design of Experiments, for data analysis, process development, and problem-solving.
Experience managing projects involving product and process changes.
Strong organizational skills and ability to work on multiple fast-paced projects simultaneously.
Minimum bachelor's degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant experience.

Nice To Haves

Excellent problem-solving ability, including demonstrated ability to design, execute, and report on experiments and draw conclusions from them.
Understanding of component manufacturing processes such as injection molding, transfer molding, thermoforming, machining, stamping, and MIM.
ISO 9001 or ISO 13485 experience, or experience in a medical device manufacturing environment.
Master's degree in an engineering discipline listed in the education requirements.
Technical skills in prototyping, tooling development, and troubleshooting.
Machine tool experience.
Basic experience with software tools or scripting, such as MATLAB or Python.
Foundation in design, fabrication, and assembly process development for complex mechanical assemblies.
Prior experience with documentation and production control systems such as Agile, SAP, or MES.
Demonstrated ability to design experiments, solve problems, and implement solutions in manufacturing.
Experience with Just-In-Time, Demand Flow Technology, and Lean Manufacturing techniques.
Prior experience with complex device manufacturing.
Experience with ERP systems, preferably SAP.

Responsibilities

Design, qualify, release, and implement tools, fixtures, and processes.
Resolve process- and hardware-related failures of varying complexity.
Identify root causes and implement solutions to improve yield and manufacturability.
Assist with product design reviews, focusing on DFX methods.
Write equipment validation protocols and line-level PPQ qualification protocols.
Create and revise work instructions for assembly and test processes, and train manufacturing team members on new content.
Manage and examine CPK and process capability data, and implement improvements based on the data.
Support Supplier Engineering, Purchasing, Planning, and Quality teams in resolving issues affecting manufacturing lines.
Create, review, and revise risk management documents such as PFMEA.
Participate effectively in sustaining and new product development teams and provide support for manufacturing lines.
Develop manufacturing equipment and refine electromechanical components, assemblies, process documentation, tooling, and test methods.
Challenge product designs to improve efficacy, reliability, manufacturability, and cost.
Travel periodically to suppliers or Intuitive manufacturing sites.