Design Controls Systems Engineer/Data Administrator Details

Design Controls Systems Engineer/Data Administrator

Intuitive - Sunnyvale, CA

Employment Type : Full-Time

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 theirmost 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.

Primary Function of Position:
We are seeking a Design Controls Systems Engineer to support the Intuitive Surgical team focused on new product development tools and processes for the Global Program Management Office (PMO). The Design Controls Systems Engineer will help develop, verify, and deploy new tools in compliance with established Design Control, Quality, and IT processes. This candidate will also help define, document, and perform data governance for complex data sets and establish procedures to ensure compliance and quality. The ideal candidate is quality focused 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 has a strong understanding of Medical Device regulations and experience implementing compliant requirements management and/or test management processes and automation tools. The position includes:

• 
  Working with cross functional teams to solve problems and execute improved tools and processes
• Analyzing, configuring, modifying and implementing Business Systems Application to help identify, communicate and resolve system issues in order to maximize the benefit for PMO and Product Operations users
• Support server configuration and monitoring to maximize uptime
• Data governance to ensure compliance and audit readiness including managing data libraries and maintaining controlled data sets
• Data maintenance including restoring content from backup and historical investigations
• Assisting in authoring and ECO release of documents needed to support additional functionality in ALM and Design Controls tools
• Test case development, execution, and documentation for computer software verification.

Skill/Job Requirements:

• 
  Understanding of Medical Devices Design Controls regulations (FDA CFR/QSIT, MDR, ISO 13485, ISO 14971)
• Requirements Management excellence including how to translate technical details into unambiguous, testable, reusable requirements and specifications
• Analyzing the effectiveness and efficiency of existing business processes and business requests, and recommend solutions using system standards and best practices
• Database configuration and maintenance including extraction, importing, transformation, and reporting
• Proof of Concept evaluations of alternate applications and demos for engineering applications identified
• System administration understanding including server maintenance, configuration, change control, feature verification and performance stress testing
• Updating system documentation and application notes in support of feature enhancements and system upgrades
• Strong communicator and relationship builder
• Detail-oriented and Quality-focused
• Excellent investigative skills

Qualifications:

• Minimum Bachelor’s Degree preferred
• Minimum 5+ years of previous related experience in medical device development, requirements management, test management, and/or regulatory documentation
• Linux administrator experience including remote server and cloud server applications
• MS Windows administrator experience
• Experience with Application Lifecycle Management tools such as Siemens Polarion, PTC Integrity, and Doors
• Excellent verbal and written communication skills
• Excellent planning and time management skills
• Highly proficient in Word, Excel, Visio, and PowerPoint
• Proficiency in Oracle/Agile helpful

All your information will be kept confidential according to EEO guidelines.

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.

Shift : Day

Travel : None