Senior Mechanical Engineer Manufacturing Equipment

3 weeks ago

Sunnyvale, United States Intuitive Full time
Company Description

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.

Job Description

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 autonomously 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
Qualifications

Required Skills and Experience
  • Minimum 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.
  • Excellent 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
  • Minimum BSME Mechanical or Mechatronics engineering with minimum of 6 years related experience.
Preferred Skills and Experience
  • 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.


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.

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 / Affirmative Action 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.

EEO and AA Policy

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.

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