Onsite Senior Design Controls Engineer – Medical Devices

Intuitive Surgical, Inc.; Sunnyvale (CA); Vor Ort; USD 102.000 - 163.000; Vollzeit

Zusammenfassung

Intuitive Surgical, Inc. in Sunnyvale, CA seeks a Design Controls Engineer within the Product Quality organization to support design, development, and regulatory compliance for medical devices. You will train teams, create content, and ensure GDP, ISO13485 and FDA 21 CFR 820 compliance, while mentoring across design and manufacturing.

Excellent writing, collaboration, and ALM/LMS proficiency are required. Join a team driving safe, effective devices and maintain DHF documentation, risk analyses,

Qualifikationen

• Bachelor's degree in engineering, science or other technical area.
• Minimum of 3 years of experience in a technical field, medical devices preferred.
• Stay current on medical devices standards for Risk Management (ISO 14971) Design Controls (ISO 13485) and FDA design control requirements (21 CFR Part 820).
• Experience working in an ISO 13485 medical device product development environment or other regulated industry.
• Experience writing and reviewing Engineering and manufacturing (design control) documents, including risk analysis, requirements, specifications, test protocols and test reports.
• Skilled in the use of Agile or similar product lifecycle management (PLM) system tool.
• Skilled in the use of Polarion or similar requirements management tool (ALM).
• Experience working with a Learning Management System (LMS).

Aufgaben

• Provide coaching and mentorship to development, manufacturing, and other stakeholders on content development, quality processes, risk analysis and Design Controls tools.
• Work with ALM developers to identify and capture learning content for tool features including best practices.
• Develop content for, review, and effectively deliver training to optimize efficacy and learner experience through channels such as online learning modules, instructor-led training, written instructional solutions, short content videos, and virtual training for users of Design Control tools.
• Respond to ticket-based requests from a variety of user channels supporting design teams.
• Research, recommend, and implement new authoring tools to improve learner experience.
• Monitor effectiveness of learning programs and materials and augment training content based on user feedback.
• Provide user feedback to the new product/feature development team to ensure user adoption of new features.
• Drive standardization of design control documents via stakeholder engagement meetings while ensure Good Documentation Practices (GDP) are followed.
• Be an ECO mentor for document ECO creator qualification, while regularly identifying new candidates to nominate for ECO document creator access.
• Assist the new product development team with compiling and updating documents for Design History Files, including risk analyses, requirements, trace reports, and design verification and validation test documentation.
• Build, produce, and refine complex trace reports using standard report templates.
• Create additional custom reports as needed.
• Assist subject matter experts with writing, reviewing, and/or editing documents required by Intuitive's design control process.
• In some cases, help author and deliver documentation and Engineering Change Orders (ECOs) related to complex documentation (e.g. complex risk analysis documents) for major design reviews.

Kenntnisse

Design Controls

GDP

Regulatory submissions

Risk analysis

ALM (Polarion)

LMS familiarity

Cross-functional collaboration

Technical writing

Ausbildung

Bachelor's degree in engineering or science

Tools

Polarion/ALM tools

Learning Management System (LMS)

MS Office (Excel/Word/PowerPoint)

Jobbeschreibung

Intuitive Surgical, Inc. in Sunnyvale, CA seeks a Design Controls Engineer within the Product Quality organization to support design, development, and regulatory compliance for medical devices. You will train teams, create content, and ensure GDP, ISO13485 and FDA 21 CFR 820 compliance, while mentoring across design and manufacturing.

Excellent writing, collaboration, and ALM/LMS proficiency are required. Join a team driving safe, effective devices and maintain DHF documentation, risk analyses,