Senior NPI Manufacturing Engineer, Single Port Systems

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.

Qualifications :

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)

Additional Information :

Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR 743.13(b)) some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employeeswho are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the governments licensing process can take 3 to 6 months) or (ii) implement a Technology Control Plan (TCP) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employeesstart date which may or may not be flexible and within a timeframe that does not unreasonably impede the hiring need. If applicable candidates will be notified and instructed on any requirements for these purposes. 

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates qualifications consistent with applicable law.

We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.

Remote Work :

No

Employment Type :

Full-time