Senior NPI Manufacturing Engineer, Single Port Systems at Intuitive — Sunnyvale, CA

Primary Function of Position

Develop, Validate, and Continuously Improve the processes and tools for low-volume manufacturing and testing of complex robotic capital equipment used for minimally invasive robotically assisted laparoscopy.

The role requires effective participation in sustaining and new product development teams, involves providing support for manufacturing lines, developing manufacturing equipment, and refining electro-mechanical components, assemblies, process documentation, tooling, and test methods. Additionally, it involves challenging product designs to improve efficacy, reliability, manufacturability, and cost for robotic surgical equipment.

Essential Job Duties

• Design, qualify, release, and implement tools, fixtures, and processes.
• Resolve failures of varying complexity, of both process and hardware nature. Identify specific root cause and implement solutions to improve yield/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 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 to resolve line facing issues.
• Create, review, and revise Risk Management documents such as PFMEA.

Required Skills and Experience

• Minimum 7+ years in a manufacturing or design-related role, or 5 years with MS in technical discipline
• Mechanical Design / Tool Design
• Strong 3D CAD and Solid Modeling skills (Solidworks preferred)
• Strong communication skills, both written and verbal. Necessary to engage with technicians, production management, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing organizations.
• ALM and PLM tools for Engineering Change Orders and Risk Management
• A continuous improvement mindset
• Knowledge of process controls, including Six-Sigma, CPk, etc.
• Technical problem-solving skills with ability to identify root cause and drive corrective action (Fishbone, 8D Analysis)
• Ability to employ statistical methods (Cpk, ANOVA, Design of Experiments,) in data analysis for process development and problem-solving.
• Able to travel periodically to suppliers or Intuitive manufacturing sites.
• Experience with managing projects around product and process changes.
• Strong organizational skills and proven ability to work on fast-paced projects simultaneously.

Required Education and Training

• Minimum BS degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant experience.

Preferred Skills and Experience

• Excellent problem solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments
• Demonstrated understanding of component manufacturing processes such as injection molding, transfer molding, thermoforming, machining, stamping, and MIM
• ISO9001, ISO 13485, or experience in medical device manufacturing environment
• MS degree in an engineering discipline listed above
• Excellent technical skills in prototyping, tooling development, and troubleshooting
• Machine tool experience
• Basic experience with software tools/scripting (eg. Matlab, Python, etc.)
• Foundation in design, fabrication, and assembly process development for complex mechanical assemblies
• Prior experience with Documentation and production control systems: Agile, SAP, MES
• Demonstrated ability to effectively design experiments, solve problems and implement them in manufacturing
• Experience in Just-In-Time, Demand Flow Technology, and Lean Manufacturing techniques
• Prior experience with complex device manufacturing
• Previous experience with ERP systems (preferred SAP)

Mandatory Notices