Staff Engineer - Systems Design - Surgical Planning

Overview

Lead the system design and technical realization of Hip Surgical Planning capabilities from concept through product release and lifecycle management.

What you'll do

• Lead the system design and technical realization of Hip Surgical Planning capabilities from concept through product release and lifecycle management.
• Understand Hip implant design philosophies and CAD models, translating implant geometry and surgical intent into planning workflows, including planar and volumetric haptics.
• Apply knowledge of CT, X-ray and MRI to develop image-based approaches for patient anatomy visualization, measurement, implant positioning and surgical planning.
• Translate user, clinical and business needs into system and subsystem requirements, specifications, interfaces and traceability.
• Perform system decomposition and allocate requirements across software, imaging, algorithms, robotics, implants and hardware.
• Lead system architecture, feasibility studies, design trade-offs, technical/design reviews and integration activities.
• Ensure requirements and system design are correctly implemented by multidisciplinary development teams and the Agile Release Train.
• Drive Design for Quality, Reliability, Safety and Serviceability and lead system-level safety/risk-management activities for regulated medical devices.
• Participate in surgeon engagements and cadaveric evaluations, translating clinical feedback into requirements and design improvements.

What you'll need

• Bachelor's or master's degree in biomedical, Computer Science, Mechanical Engineering, Biomedical Engineering, Medical Imaging Engineering, or related discipline.
• 7-10 years of strong experience in Software/Verification/Systems Engineering for medical devices, from requirements definition through verification, product release and lifecycle management.
• Experience creating system/product requirements, design specifications, architectures, interfaces and requirements traceability.
• Ability to understand Object Oriented design paradigms and communicate design in UML/SysML.
• Knowledge of medical imaging, preferably CT/X-ray, and concepts such as 3D reconstruction, segmentation, registration, anatomical landmarks and image-based measurements.
• Understanding of 3D geometry, coordinate systems, surgical planning, robotics and haptic concepts.
• Experience with medical-device risk management, safety analysis, design controls, V&V and regulatory compliance.
• Ability to troubleshoot complex system issues and support complaint investigations/root-cause analysis.
• Experience developing test methods/protocols, analyzing engineering data and producing high-quality technical reports.
• Strong written, verbal, stakeholder-management and technical-leadership skills.

Nice to have

• Experience with Hip/Total Hip Arthroplasty, surgical robotics or computer-assisted surgery, implant design philosophies, patient anatomy and clinical workflows.
• Understanding of orthopedic implants and Hip/THA surgical workflows, with the ability to interpret implant CAD and geometric design intent.
• Experience integrating implant systems into image-based planning or robotic platforms.
• Experience working directly with surgeons and participating in cadaveric evaluations.
• Working knowledge of MATLAB, Minitab, MBSE/SysML, requirements-management and CAD tools.
• Knowledge of software scripting and Object Oriented Design Principles.

Details

• Work flexibility: Hybrid.
• Travel: 20%.