- 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
- Bachelors or masters 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.
- Robust 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.