About this role
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
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Bachelor's or master’s degree in biomedical, Computer Science, Mechanical Engineering, Biomedical Engineering, Medical Imaging Engineering, or related discipline.
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7-10 years Strong experience in Software/Verification/Systems Engineering for medical devices, from requirements definition through verification, product release and lifecycle management.
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Experience creating system/product requirements, design specifications, architectures, interfaces and requirements traceability.
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Ability to understand Object Oriented design paradigms and communicate design in UML/SYSML.
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Knowledge of medical imaging, preferably CT/X-ray, and concepts such as 3D reconstruction, segmentation, registration, anatomical landmarks and image-based measurements.
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Understanding of 3D geometry, coordinate systems, surgical planning, robotics and haptic concepts.
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Experience with medical-device risk management, safety analysis, design controls, V&V and regulatory compliance.
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Ability to troubleshoot complex system issues and support complaint investigations/root-cause analysis.
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Experience developing test methods/protocols, analyzing engineering data and producing high-quality technical reports.
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Strong written, verbal, stakeholder-management and technical-leadership skills.
Preferred Qualifications
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Experience with Hip/Total Hip Arthroplasty, surgical robotics or computer-assisted surgery.
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implant design philosophies, patient anatomy and clinical workflows
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Understanding of Orthopedic implants and Hip/THA surgical workflows, with the ability to interpret implant CAD and geometric design intent.
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Experience integrating implant systems into image-based planning or robotic platforms.
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Experience working directly with surgeons and participating in cadaveric evaluations.
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Working knowledge of MATLAB, Minitab, MBSE/SysML, requirements-management and CAD tools.
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Knowledge of Software Scripting and Object Oriented Design Principles.
Travel Percentage: 20%