Senior NPI Manufacturing Engineer, Single Port Systems

About the role

The role is part of the sustaining and new product development teams, focusing on the development, validation, and continuous improvement of manufacturing processes and tools for complex robotic capital equipment used in minimally invasive robotically assisted laparoscopy.

Responsibilities

• 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.
• Aid in product design reviews with a focus on Design for X (DFX) methods.
• 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.

Requirements

• Minimum 7+ years in a manufacturing or design-related role, or 5 years with MS in technical discipline.
• 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).
• Able 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.
• Prioritize organizational skills and proven ability to work on fast-paced projects simultaneously.

Qualifications

• Minimum BS degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant 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.
• Knowledge of ISO 9001, ISO 13485, or experience in medical device manufacturing environment.
• Excellent technical skills in prototyping, tooling development, and troubleshooting.
• Basic experience with software tools/scripting (eg. Matlab, Python, etc.).
• Foundation in design, fabrication, and assembly process development for complex mechanical assemblies.
• Experience in Just-In-Time, Demand Flow Technology, and Lean Manufacturing techniques.
• Previous experience with complex device manufacturing.
• Experience with ERP systems (preferred SAP).