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System Design/Architect Engineer

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:
We are seeking an Associate Design Controls Systems Engineer to support the Intuitive Surgical team focused on new product development tools and process. The Associate Design Controls Systems Engineer will help plan, define, develop, verify, and deploy new engineering tools (for internal use) in compliance with established Design Control DOPs and associated processes. The ideal candidate is a quality-focused self-starter, with an attention to detail and a passion for helping teams innovate and deliver fully documented medical devices to market in record time. The candidate must have an understanding of Medical Device regulations and experience implementing compliant requirements management or test management processes and automation tools. The responsibilities of the position include:

  • Develops and delivers training to help drive adoption of Design Control processes and tools across the company.
  • Supports validation testing of Design Control Tools and Processes by developing testing strategy and writing test cases to ensure design requirements are met.
  • Works with cross-functional teams to identify pain points, inefficiencies, and potential areas of design control gaps.
  • Helps provide solutions and supports activities to deliver approved tools and process improvements/optimizations.
  • Enterprise-wide tools planning, development, verification, support and training.
  • Configuration, maintenance, and administration of corporate Design Controls tools and data content.
  • User support for documentation and traceability reports for regulatory submissions.
  • Developing templates and optimized workflows that improve product development productivity.
  • Supporting compliance with global medical device deliverables including submissions, DHF, and DHR.

Skill/Job Requirements:

  • Basic Understanding of Medical Devices Design Controls regulations (FDA CFR/QSIT, MDR, ISO 13485, ISO 14971)
  • Experience with using Application Lifecycle Management (ALM) Tools such as Polarion, MKS/PTC Integrity, DOORS, HP ALM
  • Strong communication skills with experience in training end users including developing training content and addressing user support questions
  • Basic understanding of database architecture and design strategy
  • Requirements Management excellence to help translate technical details into unambiguous, testable, reusable requirements and specifications
  • Knowledge of Part 11 compliance for electronic signature and digital records preferred
  • Understanding of multiple technology areas (software, mechanical, electrical, biomedical, clinical, robotics, test automation, etc)
  • Ability to help end users from cross functional teams to efficiently create fully documented, robust, and reliable medical devices
  • Detail-oriented and quality focused with excellent investigative skills



  • Minimum bachelor’s Degree required. Master’s degree preferred.
  • Minimum 1-3 years of previous related experience in medical device development, requirements management, test management, and/or regulatory documentation
  • Experience with Application Lifecycle Management tools (Siemens Polarion, PTC Integrity, Doors) preferred
  • Additional specialized training in a discipline such as software engineering, test engineering, quality, risk management, or regulatory compliance.
  • Software script writing (Python, Javascript, SQL, C) desirable
  • Excellent verbal and written communication skills
  • Excellent planning and time management skills
  • Highly proficient in Word, Excel, Visio, and PowerPoint
  • Video training experience desirable
  • Proficiency in Oracle/Agile PLM helpful

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.

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.

Base Salary Range Region 1: $93,500 - $126,500
Base Salary Range Region 2: $79,500 - $107,500
Shift: Day
Travel: None
Workplace Type: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.

The Future is Intuitive

At Intuitive, we envision a future where care is more connected, customized, and intelligent—so the question won’t just be how long we live, but how well.

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Our culture is driven by passionate people who truly want to make a difference. Learn more about our unique environment and the characteristics of people who thrive at our company.

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Our benefits overview.

We believe in supporting happy and healthy teams. As a valued team member, your benefits extend far beyond your hourly pay or salary. Learn more about our benefits and perks.

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Financial offerings

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Family Support

Family support

At Intuitive, we believe in the importance of family and seek to foster a family-friendly culture.
Healthcare Plans

Healthcare plans

Like the patients we serve, your health is also very important to us.
Growth & Development

Growth & development

Your personal and professional growth and development is important to you--and to us.

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