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.
Required Skills and Experience
- 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
- Basic understanding of database architecture and design strategy
- 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
- Detail-oriented and quality focused with excellent investigative skills
- Strong communication skills with experience in training end users including developing training content and addressing user support questions
Required Education and Training
- Bachelor’s Degree in Engineering/CS related field required. Master’s degree preferred.
- 1-3 years of previous related experience in medical device development, applications engineering, systems engineering, software development, requirements management, test management, and/or regulatory documentation
- Excellent verbal and written communication skills
- Excellent planning and time management skills
- Highly proficient in Word, Excel, Visio, and PowerPoint
Working Conditions
- Set Schedule (on-site 3+ days per week)
Preferred Skills and Experience
- 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
- Additional specialized training in a discipline such as software engineering, test engineering, quality, risk management, or regulatory compliance.
- Knowledge of Part 11 compliance for electronic signature and digital records
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.
Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.
We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.
