Job Details

Duration: 1 year
• Pay Rate: $46 per hour on w2
• Onsite/Hybrid/Remote: 4 days onsite
• Mode of interview: Telephonic/onsite
• No of rounds of interview: 2
• Exact Building number: B081

Primary Function of Position:

The Document Control Specialist plays a vital role in developing safe and effective medical devices at Intuitive Surgical. As an embedded member of the Product Engineering team, you will support the rapid and efficient development of new products, while ensuring that complete and transparent records of product designs are created and maintained.

You will work closely with a team of exceptionally talented engineers and design professionals developing highly innovative products for use in the operating room. The work of the Document Control Specialist helps safeguard the integrity of the design and ensures that Design History Files (DHFs) meet all regulatory requirements.

The Document Control Specialist 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’s technology, products, and application.

Roles and Responsibilities:

Responsibilities:
• Assist the development team with compiling and updating of engineering design control documents for Design History Files, including risk analyses, requirements, trace reports, and design verification and validation test documentation.
• Assist the cross functional development team with architecting a holistic documentation/tracing structure that is easily maintained.
• Support design team to produce high quality, consistent design documents that meet Intuitive’s design control processes.
• Use the requirements management database 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.

Activities:
• Assist subject matter experts with writing, reviewing, and/or editing documents required by Intuitive’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 Siemens Polarion as a tool to accomplish the following:
• Enter and edit documents.
• Create and edit requirements and test cases.
• Create trace links
• Produce reports using standard report templates. Create additional custom reports as needed.
• Produce trace reports.
• Use Agile as a tool to accomplish the following:
• Organize and structure Design History Files (DHF) using Design Control checklists.
• 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.

Skill, Experience, Education and Training:

Minimal Requirements:
• Bachelor’s Degree in engineering or other technical area
• Ability to understand complex technical information and translate into writing
• Proven success recognizing critical issues with the ability to react quickly under pressure, and drive issues to closure by providing coordinated direction.
• Ability to manage challenging assignments and multiple assignments in parallel
• Strong planning, decision making, negotiating and change management skills
• Assertive, outgoing personality with an ability to work collaboratively within an engineering team
• Excellent writing and communication skills.
• A high attention to detail.
• Skilled in the use of Microsoft Excel, Microsoft Word, and Adobe Acrobat

Preferred Requirements:
• 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
• Skilled in the use of Agile or similar lifecycle management system tool
• Skilled in the use of Integrity, Polarion 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)