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.

Primary Function of Position:

The successful candidate:

• Support the development/modification of software for test equipment to ensure comprehensive test coverage.
• Create, maintain, and improve “low to high-volume” manufacturing lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions.
• Apply engineering concepts to the optimization of equipment and procedures to achieve better maintainability, reliability, capacity, and availability of equipment.
• Autonomously and proactively resolves and evaluates trends for equipment performance
• Diagnose equipment breakdowns to define and implement improvement strategies.
• Resolve emergency and unscheduled problems/repairs of equipment.
• Design, document, procure, qualify, implement, and improve fixtures, tools, or equipment.
• Accountable for creation and upkeep of equipment qualification approaches (IQ/OQ/PQ/DQ) including input from risk documentation and pFMEA
• Orchestrates approach to establishing root cause and problem solving on complex issues
• Conduct testing of software releases before deploying on manufacturing line
• Execute and mentor others in manufacturing process validations, process FMEAs and other elements associated with production Master Validation Plans
• Maintain compliance with medical device quality system including corrective action closure and Change Order implementation
• Conduct SAP transactions relevant to process or equipment operations.
• Provide technician training and oversee specified manufacturing stations to ensure quality.
• Contribute to the establishment of group and personal priorities consistent with overall product development goals, including planning, priority setting, establishment of metrics, and effectively communicating progress
• Improve existing documentation for equipment installation, repair, and upkeep.
• Contributes to the successful support and advancement of mid-volume manufacturing for stapler instruments for minimally invasive robotic surgery.
• Applicant in this role must demonstrate proven design for manufacturability and mechanical design capabilities to deliver consistent improvements for production of stapler instruments.
• Applicant in this role will provide daily support for day-to-day manufacturing operations and process/mechanical design improvements for existing stapling instruments.
• The role requires effective participation in sustaining product development teams that create and refine components, assemblies, process documentation, tooling, and test methods while challenging product designs to improve efficacy, reliability, manufacturability and cost for robotic surgical instruments and accessories.
• This position will focus on meeting manufacturing operations and product safety, reliability, and performance goals.

Position Roles and Responsibilities:

Specific responsibilities for this Manufacturing Engineer position include:

• Provide technical support and failure analysis, for discrepant production components and assemblies.
• Develop, maintain, and improve manufacturing processes using pFMEA as a guide.
• Provide leadership and mentorship to team members as needed.
• Design, build, document and/or specify manufacturing assembly fixtures.
• Establish and perform IQ/OQ/PQ on equipment and fixtures. As well as execute validations on Manufacturing lines (PPQ).
• Support Design Verification and Validation (V&V) activities.
• Contribute to iterative component designs and manufacturing processes for reliability improvements and cost reductions.
• Assist supplier engineers with material procurement issues.
• Support quality system compliance including discrepant material dispositions, ECO implementation, and nonconforming evaluations.
• Accountable for supporting Corrective and Preventive Action projects and resolving quality notifications.

Preferred Skills and Experience

• Experience with C#, Python, .NET WPF application.
• Familiarity with databases (SQL, etc.)
• Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus.
• Prior experience with complex device manufacturing is a plus.
• Previous experience with ERP systems (preferred SAP) is a plus.

Skills/Experience

• Minimum BS in engineering (ME or IE disciplines) required, MS preferred.
• Minimum 5 years’ experience in product development or manufacturing environments.
• High mechanical aptitude with an exceptional background in statistics is a must.
• Experience in mid/high volume manufacturing of complex mechanisms (automation and vision system experience a plus).
• Experience with creating Manufacturing Process Instructions, Procedure writing, and BOM development.
• Ability to drive cross functional teams and give clear and concise presentations.
• CAD experience a plus (SolidWorks).
• Use of Agile or similar lifecycle management system tool.
• Experienced in ISO 13485 medical device manufacturing environment.
• Sterilized medical device experience a plus.

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 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.

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 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.

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.