Senior NPI Manufacturing Engineer – Single Port Systems
| Company | Intuitive Surgical |
|---|---|
| Location | Sunnyvale, CA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Minimum 7+ years in a manufacturing or design-related role, or 5+ years with MS in technical discipline
- Mechanical Design / Tool Design
- Exceptional 3D CAD and Solid Modeling skills (Solidworks preferred)
- Exceptional 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
- Basic 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.
- Prior experience with managing product and process changes.
- Exceptional organizational skills and proven ability to work on fast-paced projects simultaneously.
- Minimum BS degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant experience.
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.
- 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.
Preferred Qualifications
- 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)