Intuitive Surgical Careers
Design Controls Engineer
Primary Location: United States-California-US-CA-Sunnyvale
Requisition ID: 183532
Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.
Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.
Primary Function of Position:
The Design Controls Engineer plays a vital role in developing safe and effective medical devices at Intuitive Surgical. As an embedded member of the New Product Development (R&D) team, they support the rapid and efficient development of new products, while ensuring that complete and transparent records of product designs are created. They work closely with a team of exceptionally talented engineers and design professionals developing highly innovative products for use in the operating room. Their work helps safeguard the integrity of the design and ensures that Design History Files (DHFs) meet all regulatory requirements. The Design Controls Engineer is expected to bring to their role a passion for proper design control methodology, a strong sense of pride in their work output, and a real interest in Intuitive Surgical’s technology, products, and application.
- Assist the new product development team with compiling and updating engineering design control documents for Design History Files, including risk analyses, requirements, and design verification and validation test documentation.
- Support design team to produce high quality, consistent design documents that meet Intuitive Surgical’s requirements.
- Coordinate with other departments as necessary in order to assure that product documentation (including user manuals, labeling, and training) is consistent with design documentation.
- Use traceability database software tool extensively to manage design control documents and the links between document content.
- Seek out new and better ways of creating DHF documents, make recommendations for improvements, and then work with leadership to make those improvements a reality.
- Assist subject matter experts with writing, reviewing, and/or editing documents required by Intuitive Surgical’s design control process, including requirements, risk analyses, specifications, test protocols and design review checklists.
- Coordinate documentation and Engineering Change Orders (ECOs) related to major design reviews.
- Produce requirements trace mapping and associated documentation.
- Use MKS as a tool to accomplish the following:
o Enter and edit documents.
o Create and edit requirements and test cases.
o Create trace links
o Produce reports using standard report templates. Create additional custom reports as needed.
o Produce trace reports.
Use Agile as a tool to accomplish the following:
o Organize and structure Design History Files (DHF) using Design Control checklists.
o Prepare and submit ECOs for individual documents and for DHF Bill of Material (BOM) changes.
- Work with the Technical Publications department to assure that Manuals, Instructions for Use, Labels and Training Materials are consistent with design documentation. Create trace documents and protocols used to assist in this process.
- Bachelor’s Degree in engineering or other technical area
- Ability to understand complex technical information and translate into writing
- Minimum 3 years’ experience working in an ISO 9001 medical device product development environment or other regulated industry
- Experience writing and reviewing engineering (design control) documents, including specifications, test protocols and test reports
- Ability to manage challenging assignments and multiple assignments in parallel
- Assertive, outgoing personality with an ability to work collaboratively within an engineering team
- Excellent writing and communication skills, and attention to detail
- Skilled in the use of Microsoft Excel and Word
- Skilled in the use of Agile or similar lifecycle management system tool
- Skilled in the use of MKS, Doors or other requirements management tool
- Development experience with complex systems with a combination of hardware and software
- Experience in Risk Analysis and Failure Modes and Effects Analysis (FMEAs)
We are an AA/EEO/Veterans/Disabled employer.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.