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.
Essential Job Duties
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 some cases, help author and deliver documentation and Engineering Change Orders (ECOs) related to complex documentation (e.g. complex risk analysis documents) for major design reviews
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
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.
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 HRHelpNow@intusurg.com.
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.
