Sr NPI Manufacturing Engineer

About the role

Primary Function of Position

This highly skilled manufacturing engineer will support flexible instruments and accessories for the Ion platform. This engineer must be able to develop new and improved manufacturing processes by collaborating across functions to solve a wide variety of technical process and equipment problems. They will have demonstrated experience developing and improving flexible instruments and/or catheter manufacturing processes such as lamination, thermal bonding, injection modling and UV-cured adhesives.

Essential Job Duties

• Contribute to the development of new manufacturing processes:
• Experience in early development of flexible instrument manufacturing processes, including process tradeoff assessments
• Experience working with a wide range of plastic and metal joining processes, such as laser welding, adhesive bonding, lamination/plastic reflow, injection molding
• Comfortable with experiment design (DOE) to identify and control critical process parameters - demonstrated successful transfer of complex manual processes to high volume, high capability
• Experience developing flexible instrument/catheter manufacturing lines - establishing order of operations, building and testing prototypes, training operators, defining fixture/tooling requirements, and conducting process validation
• Maintains connections with leading catheter manufacturing equipment suppliers and is aware of latest state-of-the-art processes and equipment
• Proven track record of working upstream with product design engineers and can be the voice of manufacturing on product development teams
• Support Ion manufacturing lines including:
• Establish regular communication with the production team to ensure they have the best support possible for both short and long term needs
• Manage product reliability improvements from concept to implementation
• Identify, design, qualify, document and introduce assembly/test fixtures and equipment
• Improve process flows of Ion instrument manufacturing lines to optimize for manufacturability - e.g. reliability, efficiency, capacity, and safety
• Execute and mentor others in manufacturing process validations, process FMEAs and other elements associated with production Master Validation Plans
• Manage manufacturing strategy and production capability for Ion Instrument lines to minimize customer backorders
• Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition and Engineering Change Order (ECO) implementation
• Provide technical support for failure analyses and root cause investigations of product failures
• Contribute to the establishment of group and individual objectives consistent with overall product development goals, including priority setting, establishment of metrics, and effectively communicating progress
• Provide resource budget estimates for product and process improvements, tooling development, and testing
• Works with Quality and Regulatory to ensure that the team follows appropriate GMP, design history file (DHF), and device history record (DHR) guidelines per FDA requirements

Required Skills and Experience

• Strong technical analytical skills and troubleshooting skills
• Prior responsibility for validation/verification of processes, equipment and products
• Strong organizational skills and proven ability to work on several fast-paced projects simultaneously
• Prior experience with managing product and process changes
• Prior experience with technical writing
• Able to communicate effectively and professionally with cross-functional peers, executive leadership, internal customers and external suppliers

Required Education and Training

• Minimum BS degree in Engineering discipline, MS preferred
• Minimum 8 years of experience as design or manufacturing engineer supporting product with significant mechanical, electromechanical, or electro optical content.

Preferred Skills and Experience

• Experienced in ISO 13485, ISO 9001, or medical device manufacturing environment, Six Sigma Black/Green Belt is a plus
• Prior experience with Design Control processes for medical devices and/or clinical applications of the surgical instruments, and/or automated equipment design is a plus
• Fundamental understanding of engineering plastics, especially medical grade polymers and metals is a plus (e.g. Nitinol, PTFE, Pebax, PET, Nylon)
• Familiar with mechanical CAD software (SolidWorks) is a plus
• Strong technical analytical skills, background in material bonding, catheters and vision-related products is a plus
• Background in material bonding, catheters and vision-related products
• Familiar with the fundamentals of injection molding

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.

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 employees who 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 government's 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 employee's start 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.

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 candidate's experience, knowledge and skills.

Compensation will be based primarily on the job level at which the role is filled and the candidate's qualifications, consistent with applicable law.

Accommodation & Accessibility Notice

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.