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Key Highlights as a Medical Device Developer:

  • 🤖 Robotic Innovation: Played a key role in the development of a first-of-its-kind robotic breast biopsy system, aimed at automating tissue sampling procedures to increase accuracy and reduce human error in clinical workflows.

  • 🔩 Mechanical Subsystem Design: Designed and prototyped precision mechanical subassemblies, including linear actuators, mounting fixtures, and sensor housings, with a focus on mechanical robustness, tight tolerances, and ergonomic integration.

  • 🧠 Multidisciplinary System Integration: Collaborated on the integration of hardware components, embedded control systems, and imaging modules, ensuring smooth motion control, real-time feedback, and reliable system performance across multiple iterations.

  • ✅ Verification & Validation: Supported design verification and validation (DV&V) protocols including bench testing, failure mode analysis (FMEA), and tolerance stack-up reviews, helping to ensure system safety, repeatability, and regulatory readiness.

  • 📊 Risk & Compliance: Actively participated in risk management activities in accordance with ISO 14971, contributing to hazard identification, risk control implementation, and documentation of mitigations in technical files.

  • 📁 Design Control & Documentation: Contributed to Design History Files (DHF) and maintained traceable documentation aligned with ISO 13485 and FDA 21 CFR Part 820 requirements, supporting future clinical validation and regulatory submissions.

  • 👩‍⚕️ Clinical Collaboration: Worked cross-functionally with clinicians, biomedical engineers, and software developers to translate clinical needs into design requirements, ensuring the system was user-friendly, safe, and purpose-built for real-world surgical environments.

My work involved developing and validating a novel robotic system for automated breast biopsies, contributing to hardware design, prototyping, and performance testing to ensure safety, precision, and clinical reliability. 

JENNIE Bot - Autonomous Breast Biopsy Robot

  • Mechanical Design & Prototyping: Designed and developed custom mechanical components such as biopsy guides, actuator mounts, and structural housings using CAD tools, with iterative prototyping to refine ergonomics, alignment, and durability.

  • Motion Control & Actuation: Assisted in the integration and tuning of stepper motors and linear actuators to ensure smooth, accurate needle insertion paths, optimizing mechanical performance and procedural safety.

  • Sensor & Feedback Systems: Helped integrate force sensors, encoders, and limit switches into the robotic system to enable real-time feedback and enhance the system’s responsiveness and safety during tissue engagement.

  • System Assembly & Bench Testing: Participated in hands-on assembly of robotic prototypes and executed bench testing to evaluate performance metrics such as insertion precision, repeatability, and mechanical reliability.

  • Imaging & Navigation Alignment: Supported the alignment of robotic mechanisms with imaging modalities, ensuring proper calibration between the robot’s coordinate system and real-time ultrasound or mammography inputs for guided procedures.

  • Design Verification & Risk Management: Contributed to design verification activities and risk assessments (FMEA), identifying potential failure modes and implementing design mitigations to support compliance with ISO 14971 and other regulatory standards. 

  • Cross-Functional Collaboration: Worked closely with biomedical engineers, software developers, and clinical end users to translate surgical requirements into actionable design improvements, ensuring the system was intuitive, safe, and clinically viable.

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Key Strengths & Expertise:

Robotic System Development & Engineering

  • 🤖 Robotic Design & Integration: Supported the development of a robotic breast biopsy platform, integrating mechanical, electronic, and control subsystems.

  • ⚙️ Motion Systems & Actuation: Assisted in calibrating and tuning actuators, optimizing motion precision for tissue targeting and insertion control.

  • 🧠 Sensor Feedback Systems: Integrated force sensors and limit switches to enable real-time feedback, ensuring safe, responsive system behavior during biopsy procedures.

Medical Device Design & Prototyping

  • 📐 Mechanical Subassembly Design: Designed and iterated CAD-based components including biopsy guides, actuator mounts, and fixture housings.

  • 🖨️ Rapid Prototyping & Testing: Used 3D printing and bench testing to evaluate component fit, function, and durability in simulated clinical conditions.

  • 🔧 Functional Validation: Conducted performance validation of device subsystems under controlled test environments to ensure robustness and alignment with design inputs.

Verification, Validation & Risk Management

  • ✅ Design Verification & V&V Protocols: Executed verification and validation testing, supporting tolerance analysis, mechanical endurance testing, and design traceability.

  • 📊 FMEA & Risk Analysis: Contributed to Failure Mode and Effects Analysis (FMEA), identifying system-level risks and proposing design mitigations per ISO 14971.

  • 📁 Design Documentation: Maintained design outputs in alignment with Design History File (DHF) structure and supported documentation for regulatory compliance.​

Cross-Functional Collaboration & Clinical Focus

  • 👩‍⚕️ User-Centered Design: Worked closely with surgeons and clinical advisors to integrate feedback into design revisions, improving ergonomics and usability.

  • 🤝 Cross-Disciplinary Communication: Collaborated with software, electrical, and regulatory teams to align development timelines and technical milestones.

  • 📋 Test Planning & Reporting: Helped create test protocols and technical summaries for internal review and potential regulatory submissions.

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