Staff Engineer - Systems Design - Surgical Planning

Stryker Global Technology Center Pvt Ltd.; Gurugram District; Hybrid; INR 1,800,000 - 2,800,000; Full time

Job summary

Stryker in Gurugram, India, seeks a senior Systems Engineer to lead the system design and technical realization of Hip Surgical Planning capabilities from concept through product release and lifecycle management.

You will translate implant geometry and surgical intent into planning workflows, coordinate across software, imaging, robotics and hardware teams, perform risk management and design reviews, and engage with surgeons to refine requirements.

Qualifications

• 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/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.

Responsibilities

• Lead the system design and technical realization of Hip Surgical Planning capabilities from concept through product release and lifecycle management.
• Translate 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 and surgical planning.
• Translate user, clinical and business needs into system and subsystem requirements, specifications and interfaces.
• Perform system decomposition and allocate requirements across software, imaging, algorithms, robotics, implants and hardware.
• Lead system architecture, feasibility studies, design trade-offs and integration activities.
• Ensure requirements and system design are implemented by multidisciplinary teams and the Agile Release Train.
• Drive Design for Quality, Reliability, Safety and Serviceability and lead safety/risk-management activities for regulated medical devices.
• Participate in surgeon engagements and cadaveric evaluations, translating clinical feedback into requirements and design improvements.

Skills

Biomedical engineering

Software/Systems engineering

UML/SYSML

Image-based planning

Regulatory compliance

Risk management

Cross-functional leadership

Medical imaging

3D geometry

Troubleshooting

Education

Bachelor's/Master's in Biomedical Engineering or related

Tools

MATLAB

Minitab

MBSE/SysML

CAD tools

Job description

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%

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com

Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.