Design Control Engineer 3

Intuitive; Sunnyvale (CA); On-site; USD 102,000 - 113,000; Full time

Job summary

Intuitive is hiring a Design Controls Engineer to join the Product Quality organization, focusing on safe, compliant medical device design and documentation. This role supports training, content development, and governance of GDP for regulatory submissions.

You will collaborate with Design Engineering and New Product Introduction teams, mentor stakeholders, and help implement new tools and best practices to enhance design control documentation quality.

Qualifications

• Bachelor’s degree in engineering, science or other technical area.
• Minimum 3 years of experience in a technical field; medical devices preferred.
• Experience with ISO 14971, ISO 13485 and 21 CFR Part 820 regulatory requirements.
• Experience writing and reviewing design control documents and risk analyses.

Responsibilities

• Provide coaching on design controls, quality processes, and risk analysis to diverse stakeholders.
• Develop and deliver training content for Design Controls tools and processes.
• Assist with regulatory submissions and regulatory documentation maintenance (DHF) as needed.
• Support ECOs and GDP adherence across design control documents.

Skills

Agile PLM experience

Technical writing

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor’s degree in engineering, science or technical area

Tools

Polarion ALM

LMS (Learning Management System)

MS Office (Excel/Word/PowerPoint)

Job description

• Ways of Working: Set Schedule - This job will be onsite weekly, the percentage of onsite work will be defined by the leader.
• Employee Type: Employee
• Min. Salary Region 1: 113200 USD
• Global Job Level (HCM): Professional 3 (9)
• Min. Salary Region 2: 101900 USD

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Job Description

Primary Function of Position

The Design Control Engineer contributor within the Product Quality organization, responsible for
supporting the design and development of safe, effective, and compliant medical device products.

The Design Controls Engineer is responsible for assisting and training Design Engineering and New Product
Introduction teams with their regulatory and quality documentation deliverables in support of Design
Control milestones and DHF maintenance. You will be responsible for direct user support in addition to
content development and training delivery for Design Controls tools. As process and tools experts, the
Design Controls Engineer also assists users with complex documentation activities supporting regulatory
submissions and investigations. As a Risk Management and Design Controls expert, the Design Controls
Engineer assists users on data governance, compliance (including GDP), and quality assurance of DHF
documentation used for regulatory submissions and audit.

• Provide coaching and mentorship to development, manufacturing, and other stakeholders oncontent development, quality processes, risk analysis and Design Controls tools
• Work with ALM developers to identify and capture learning content for tool features including best practices
• Develop content for, review, and effectively deliver training to optimize efficacy and learner experience through channels such as online learning modules, instructor-led training, written instructional solutions, short content videos, and virtual training for users of Design Control tools
• Respond to ticket-based requests from a variety of user channels supporting design teams
• Research, recommend, and implement new authoring tools to improve learner experience
• Monitor effectiveness of learning programs and materials and augment training content based on user feedback.
• Provide user feedback to the new product/feature development team to ensure user adoption of new features
• Drive standardization of design control documents via stakeholder engagement meetings while
• ensure Good Documentation Practices (GDP) are followed
• Be an ECO mentor for document ECO creator qualification, while regularly identifying new candidates to nominate for ECO document creator access

The following job duties are secondary and will decrease over time with wider tool adoption and
increased user skills:

• Assist the new product development team with compiling and updating documents for Design History Files, including risk analyses, requirements, trace reports, and design verification and validation test documentation
• Build, produce, and refine complex trace reports using standard report templates.
• Create additional custom reports as needed
• Assist subject matter experts with writing, reviewing, and/or editing documents required by Intuitive’s design control process
• In somecases, help author and deliver documentation and Engineering Change Orders (ECOs) related to complex documentation (e.g. complex risk analysis documents) for major design reviews

Qualifications

Required Skills and Experience

• Bachelor’s degree in engineering, science or other technical area
• Minimum of 3 years of experience in a technical field, medical devices preferred
• Stay current on medical devices standards for Risk Management (ISO 14971) Design Controls (ISO 13485) and FDA design control requirements (21 CFR Part 820)
• Experience working in an ISO 13485 medical device product development environment or other regulated industry
• Experience writing and reviewing Engineering and manufacturing (design control) documents,
  including risk analysis, requirements, specifications, test protocols and test reports
• Skilled in the use of Agile or similar product lifecycle management (PLM) system tool
• Skilled in the use of Polarion or similar requirements management tool (ALM)
• Experience working with a Learning Management System (LMS)

Preferred Skills and Experience

• Ability to work cross-functionally as well as operate independently when necessary
• Ability to create solution oriented strategies and execute on goals within set timelines and budgets
• Solid organizational, time management and prioritization skills
• Strong interpersonal skills and emotional intelligence
• Ability to manage challenging assignments and multiple assignments in parallel
• Strong service-oriented qualities with an ability to work collaboratively with multiple Engineering teams
• Excellent writing and communication skills, and attention to detail
• Skilled in the use of Microsoft Excel, Word, and PowerPoint
• Ability to develop others through structured learning experience, feedback strategies, and coaching

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 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.

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 employeeswho 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’sstart 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.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.

Accommodation & Accessibility Notice:

Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at [e-mail].

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.

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