Senior NPI Manufacturing Engineer

Intuitive•Sunnyvale, CA

2d•$132,900 - $225,000•Onsite

About The Position

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

Requirements

At least 7 years in a manufacturing or design-related role, or 5 years with a master's degree in a technical discipline.
Minimum bachelor's degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant experience.
Mechanical design and tool design skills.
Strong 3D CAD and solid modeling skills; SolidWorks preferred.
Strong written and verbal communication skills for engaging with technicians and cross-functional organizations.
Experience with ALM and PLM tools for Engineering Change Orders and risk management.
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 such as Cpk, ANOVA, and Design of Experiments for data analysis, process development, and problem-solving.
Ability to travel periodically to suppliers or Intuitive manufacturing sites.
Experience managing projects involving product and process changes.
Strong organizational skills and proven ability to work on multiple fast-paced projects simultaneously.

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, ISO 13485, or medical-device manufacturing experience.
Master's degree in a listed engineering discipline.
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.
Experience with documentation and production control systems such as Agile, SAP, and 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; SAP preferred.

Responsibilities

Design, qualify, release, and implement tools, fixtures, and processes.
Resolve process and hardware failures, identify root causes, and implement solutions to improve yield and manufacturability.
Assist in product design reviews with a focus on DFX methods.
Write validation protocols for equipment and PPQ protocols for line-level qualification.
Create and revise work instructions for assembly and test processes, and train the manufacturing team on new content.
Manage and examine data for CPK and process capability, and implement improvements based on data.
Support Supplier Engineering, Purchasing, Planning, and Quality teams in resolving line-facing issues.
Create, review, and revise risk-management documents such as PFMEA.
Participate effectively in sustaining and new product development teams and support manufacturing lines.
Develop manufacturing equipment and refine electro-mechanical 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.