Staff Engineer - Systems Design - Surgical Planning

Work Flexibility: Hybrid
What you will 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 will need:
Required Qualifications
Bachelor's or master’s degree in biomedical, Computer Science, Mechanical Engineering, Biomedical Engineering, Medical Imaging Engineering, or related discipline.
7-10 years 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.
Preferred Qualifications
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.
Travel Percentage: 20%

Skills
Agile, Risk Management, MATLAB, Regulatory Compliance