Senior Mechanical Engineer Manufacturing Equipment

Primary Function of Position

Design and construct manufacturing equipment used to produce minimally invasive medical devices.  This manufacturing equipment will range in complexity from custom manual fixtures to semi-automated electro-mechanical systems, integrating workholding, sensing, motion and vision control.  This position will play a critical role in developing cutting edge manufacturing capabilities to enable the future of minimally invasive surgery.

The ideal candidate should have a solid understanding of the technical aspects of mechanical engineering and design. He/she will work closely with senior level equipment staff and other departments to develop and sustain custom equipment for production use. This person will thrive working independently on projects with medium to high complexity.

Essential Job Duties

• Design and build in-house manufacturing equipment from concept to implementation.

• Create effective design solutions of mechanical assemblies from simple fixturing to more complex assembly for automation equipment.

• Ensure manufacturing equipment designs meet functional, safety, ergonomic, documentation, and validation requirements.

• Create and manage project plans including schedules, budgets, and stakeholder updates.

• Develop documentation for equipment including specifications, assembly instructions, maintenance, and calibration procedures.

• Create and execute protocol documentation for equipment DQ, IQ, OQ, PQ validations.

• Conduct effective design reviews of new equipment at all stages of development.

• Provide equipment-related technical support for on-going production operation and expansion.

• Establish and manage external resources (contractors, system integrators, vendors) in the planning and execution of equipment projects.

• Support quality and internal/external audits as required

• Support other equipment-related operations and duties as required

Required Skills and Experience

• BSME or similar.

• Minimum 4 years’ experience designing and developing automated manufacturing equipment.

• Self-motivated, works well with others in a team environment.

• 3D CAD proficiency, SolidWorks preferred.

• Experience in integration of mechatronics components such as sensors, motors, pneumatics, and motion and vision control components.

• Strong understanding of tolerance analysis and statistical methods.

• Experience troubleshooting and repair of manufacturing equipment.

• Experience developing equipment qualification, calibration and PM procedures and practices.

Required Education and Training

BSME Mechanical or Mechatronics engineering with minimum of 6 years related experience.

Working Conditions

None

Preferred Skills and Experience (As applicable - Specific skills, knowledge, and experience that are not required to perform the job, but are desirable to have)

• MSME (or equivalent) with minimum 6 plus years prior experience.

• Prior experience developing and supporting catheter manufacturing equipment.

• Knowledge in equipment control systems, PLC (Beckhoff preferred).

• Prior experience working with PLM systems (Agile preferred), SAP applications, including ECO creation, origination of equipment specification, test protocols, BOM, and work instructions.

• Structured Problem Solving. Rational thinking and root cause analysis capability.

• Experience with enterprise software (e.g. Agile document control, Confluence, Polarion, Windchill, etc…)

• Experience working in a medical device or other regulated quality systems.

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 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. 

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 compensation ranges are listed.