Applications Engineer
4 weeks ago
We are seeking a skilled engineer to join our team at Intuitive Surgical. As a pioneer in robotic-assisted surgery, we strive to foster an inclusive and diverse team committed to making a difference in the world of minimally invasive care.
The ideal candidate will have a strong understanding of medical device design controls regulations and experience implementing compliant requirements management or test management processes and automation tools.
Key Responsibilities:
- Support validation testing of Design Control Tools and Processes
- Design and implement UI features and ancillary scripts using Python, JavaScript, SQL, and Velocity
- Work with cross-functional teams to identify pain points, inefficiencies, and potential areas of design control gaps
- Collaborate with business stakeholders to understand requirements and translate them into solutions
- Develop tools, templates, and optimized workflows that improve product development productivity
- Support compliance with global medical device deliverables including submissions and DHFs
Requirements:
- Basic understanding of Medical Devices Design Controls regulations (FDA CFR/QSIT, MDR, ISO 13485, ISO 14971)
- Programming skills in Python, JavaScript, Velocity, SQL, and/or HTML
- Requirements Management excellence to help translate technical details into unambiguous, testable, reusable requirements and specifications
- Understanding of multiple technology areas (software, mechanical, electrical, biomedical, clinical, robotics, test automation, etc)
- Ability to help end users from cross-functional teams to efficiently create fully documented, robust, and reliable medical devices
Preferred Qualifications:
- Proficiency in Oracle/Agile
- Experience with using automated test execution tools such as but not limited to MF ALM
- Experience with using Application Lifecycle Management (ALM) Tools such as Polarion, MKS/PTC Integrity, DOORS, HP ALM
We offer a competitive compensation package, inclusive of base pay, incentives, benefits, and equity. If you are a motivated and detail-oriented engineer looking to make a difference in the medical device industry, please submit your application.
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