Job Description
Primary Function of Position
We are seeking an engineer to support the Intuitive Surgical team focused on new product development tools and process. The engineer in this position will help develop, verify, and deploy new engineering tools (for internal use) and processes in compliance with established Design Control DOPs and associated processes. The ideal candidate is a quality focused self-starter with excellent problem-solving skills, a keen attention to detail and a passion for software architectures and processes. The candidate must have a functional understanding of Medical Device regulations and experience implementing compliant requirements management or test management processes and automation tools.
Essential Job Duties
- Support validation testing of Design Control Tools and Processes by following testing strategy and writing test cases to ensure design requirements are met.
- Design and implement UI features and ancillary scripts using Python, JavaScript, SQL and Velocity
- Test and debug scripts, queries, dashboards, and reports from tools
- 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 to deliver approved tools and process improvements/optimizations.
- Enterprise-wide tools development, verification, support, and training.
- Configuration, maintenance, and administration of corporate Design Controls tools and data content.
- Develop tools, templates and optimized workflows that improve product development productivity.
- Support compliance with global medical device deliverables including submissions and DHFs.
- Develop and assist in delivery of training to help drive adoption of Design Control processes and tools across the company.
- User support for documentation and traceability reports for regulatory submissions.
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