NPI Manufacturing Engineer at Intuitive Surgical, Inc. in Sunnyvale, California

Job Description:

At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Our mission is our guiding force; our culture is the DNA that makes us unique.

As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare's complex challenges.

We believe a great idea can come from anywhere-inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and strive to achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's help to advance the world of minimally invasive care.

You will own the manufacturing content for new product introductions and participate with product development teams that specify, build, test and challenge new product designs to improve efficacy, reliability, serviceability, manufacturability and cost.

Roles and Responsibilities:

• Provides product and process DFx (Manufacturing, Assembly) input to Product Development Engineering to enhance manufacturability and product cost.
• Supports new products during pilot production phase through successful and sustained project launch. This includes supporting new product introduction schedules, resolving manufacturability issues, and driving improvements for cost and efficiency.
• Proactively evaluate and challenge designs for technical merit, reliability, serviceability and manufacturability working with the design team to realize optimal outcomes.
• Creates an efficient "low- to mid-volume" manufacturing assembly line, specifying and/or refining BOMs, work flows and detailed work instructions. This includes developing the process flow, and manufacturing process instructions (MPIs), including test procedures
• Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ/PPQ).
• Responsible for maintaining compliance with medical device quality system requirements including corrective/preventive action closure, discrepant material dispositions and change order creation, review and implementation.
• Provide technical support for failure analysis of discrepant production components, assemblies and field returns.
• Participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining of supply chain.

Skill/Job Requirements:

This role requires active participation to create and refine electro-mechanical components, assemblies, process documentation, tooling and test methods for robotic surgical instruments. The successful candidate will have achieved the following:

• BS Mechanical Engineering; MSME preferred
• 3+ years' experience as design or manufacturing engineer supporting product with significant mechanical content. MSME acceptable compensation for 1 years' experience.
• Solid modeling/CAD experience (SolidWorks preferred).
• Demonstrated understanding of manufacturing processes including injection molding, machining, stamping, laser welding, design of experiments, and capability analysis.
• Foundation in design, fabrication and assembly of complex assemblies with demonstrated knowledge of mechanical assembly techniques, test methods included gage R&R analysis, DFx, and lean principles.
• Technical skills in prototyping, tooling development, process engineering, and troubleshooting.
• References who will validate you as a strong a team player, self-starter, and possessing a can-do attitude!
• Strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers.
• Strong problem solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments.
• Excellent organization, follow-up and documentation skills.
• Comfortable interacting with technicians, engineers, and management all on a regular basis.

Highly preferred skills & experience:

• Electromechanical new product development experience preferred.
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus.
• Machine tool experience a plus.

Intuitive is an Equal Employment 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.

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

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