Senior NPI Manufacturing Engineer

At Intuitive, we are united behind our mission: 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.
As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.
Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.
Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world 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 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 advance the world of minimally invasive care.

This Senior New Product Introduction Manufacturing Engineer (Senior NPI Engineer) position reports to the Manufacturing Engineering Manager for Da Vinci Single Port Surgical System’s Instrument products. In this position, the Senior NPI Engineer utilizes their in-depth manufacturing, equipment, and design knowledge to collaborate with design engineering to discover, define, develop, and validate new assembly and test equipment along with assembly process solutions. Their primary focus is to develop assembly and test processes, establish engineering requirements, consider process risks, and identify solutions to guide development. Ultimately they implement and optimize assembly process equipment, fixturing, and test solutions. They focus on opportunities for poka-yoke, DfX, semi-automated and automated solutions, and design for assembly opportunities to achieve optimal safety, reliability, serviceability, manufacturability, and cost.

After production release, and as needed for current released products, they act as the “first line of defense” by providing sustaining support to the manufacturing line while driving continuous improvement of manufacturing processes, equipment, and maintenance procedures. They perform comprehensive failure analysis to identify root cause of emergent production issues, efficiently documenting, mitigating, and closing of non-conformances, and performing requalification of production equipment.

Roles and Responsibilities:

Technical Expertise

• Exceptional mechanical engineering skills with demonstrated proficiency in manual assembly techniques. Mechanical design experience is required.
• In-depth knowledge of equipment and methods to implement assembly and test processes of complex medical devices.
• Proven diverse capability to adapt and work with support teams on software, algorithms, electronics aspects of the device, and human interface needs.
• Proactively evaluates and challenges designs for technical merit, reliability, serviceability, and manufacturability while working with design partners to realize optimal outcomes.
• Provides a voice for the manufacturing process of Intuitive’s products. Leads product and process DfX (Manufacturing, Assembly) input to Product Development Engineering to enhance manufacturability and product cost.
• Proven ability to identify and assess potential process risks and mitigations and maintain currency of process FMEA and other quality records.
• Own and drive continuous improvement of quality, throughput, and cost during development and after product market release. Utilize analytical objective data and statistical analysis to inform and drive conclusions.
• Creates an efficient manufacturing assembly line, specifying and/or refining BOMs, workflows and detailed work instructions. This includes developing the process flow at the unit operation level, creating manufacturing process instructions (MPIs), and developing requirements for processes and test equipment.
• Responsible for the validation, qualification, and documentation 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.
• Provides technical support for failure analysis of discrepant production components, assemblies, and field returns. Leads investigations with a cross-functional team to identify root cause, establish mitigations, and drive implementation using tools such as 8D, DMAIC, 5-Why, Fishbones, etc..

Leadership Requisites

• Owns new products during pilot production phase through successful and sustained project launch. This includes driving new product introduction schedules, resolving manufacturability issues, and driving improvements.
• Guides/participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining continuity of material supply.
• Mentors and sets project tasks for Manufacturing Engineers on their specific project team, and on other teams as needed, to further company expertise & effectiveness.
• Establish milestones, support, and success criteria for responsible projects. Drive outcomes and escalate key issues quickly maintaining stakeholder alignment.
• Keep the organization’s vision and values at the forefront of decision-making and action.

Skill/Job Requirements:

This role requires effective participation to create and refine electro-mechanical components, mechanical assemblies, process documentation, tooling and test methods for robotic surgical instruments. The emphasis is on the mechanical design of manufacturing processes and assembly equipment. The successful candidate will have achieved the following:

• BS Mechanical, Biomedical, or Manufacturing Engineering with 8 years minimum related experience; MSME, MSBMED, or MSMfgE with 6 years minimum related experience preferred. Related experience is as a design or manufacturing engineer supporting a product with significant mechanical content.
• Demonstrated project leadership and exceptional communication skills to drive assembly equipment, fixturing, and tooling design from development through implementation.
• Exceptional solid modeling/CAD experience (SolidWorks preferred).
• Demonstrated understanding of manufacturing processes including injection molding, machining, stamping, laser welding, design of experiments, and capability analysis. Experience with automation highly desired.
• Excellent foundation in design, fabrication, and assembly of complex assemblies with demonstrated knowledge of mechanical assembly techniques, test methods including gage R&R analysis, DfX, and lean principles.
• Ability to effectively use statistical methods in data analysis for process development, problem-solving, statistical process control, etc
• Excellent technical skills in prototyping, tooling development, process engineering, and troubleshooting.
• References who will validate you as an exceptional a team player, self-starter, and possessing a can-do attitude!
• Comfortable interacting with engineers, management, technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers.
• Excellent problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments.
• Excellent leadership, organization, follow-up, and documentation skills.

Highly preferred skills & experience:

• Electromechanical new product development experience preferred.
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus.
• Experience implementing DfX changes to new or established product preferred.
• Machine tool experience a plus.
• Medical device experience preferred but not required.

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.

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

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 salary ranges are listed.

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

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.

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 salary ranges are listed.