Team member - Simulation engineering

Division

Department

Sub Department 1

Job Purpose

The role is expected to provide the expertise in engineering simulation for the department and conduct engineering simulation projects across the medical devices under development for the standalone, combination products in Cipla markets as well as global regulatory markets

Key Accountabilities (1/6)

Design of simulation experiments

• Create a simulation framework in the development of standalone or combination product devices by defining the problem statement, need and objectives of the simulation studies (e.g. physics, failure modes, risks, safety etc)
• Build a design for simulation to be done and validate with HOD

Key Accountabilities (2/6)

Identifying the root cause, failure modes and limitations of the devices in development and suggest improvement plan

• Carry out primary model development in simulation software and conduct simulation experiments as per design
• Identify the simulation suggested failure modes and limitations of the devices in development and suggest improvement plan to the development team
• Validate the simulation predictions by comparing the insights with the development team

Key Accountabilities (3/6)

Identify, institutionalize novel simulation tools for future projects and for potential clinical waivers for the US market

• Build simulation toolkit consistent with the current expectations of the global regulatory agencies such as US FDA, MHRA, EU notified bodies and scientific bodies such as ASME, Pharma Compendium, IS etc.
• Define outputs from simulations as per requirements of Indian CDSCO guidelines, CE marking etc. for the device master file of standalone medical devices
• Define the exact output of simulations in leu of the patient safety and drug delivery efficacy to support clinical waiver applications to the agencies for pipeline projects

Key Accountabilities (4/6)

Manage and maintain compliance portals for simulations at Cipla used for regulatory submissions

• Manage the compliance of the simulation models developed, their validation and verification, the final compliant runs and submission to the regulatory bodies
• Keep the compliance portals e.g. MINERVA, SDMS, ELN datasheets up to date for all the simulations for potential audits, Quality inspections and as per Cipla SOPs.
• Keep the design and simulation runs of the models up to date with regulatory guidance and product specific guidance

Key Accountabilities (5/6)

Work with Group leader and vendors to conduct validation experiments to validate the model and secure IP for Cipla on in-silico models

• Work with Group leader and vendors to conduct validation experiments to validate the model and secure IP for Cipla on in-silico models
• Build lab based tools, experiments, prototyping models for the device or testing jigs to measure the experimental output relevant to the simulation models and document the validation process for the model thus completed

Key Accountabilities (6/6)

Major Challenges

• Validation and credibility of the model and simulations acceptable to regulatory bodies
• Early identification of design, production and scale up failures in the devices under development
• Delay in simulation design, experimentation and compliant reporting for the US programs causing the delay on product filing and approval timelines  

Key Interactions (1/2)

Internal

• Cipla Devices team “ device design understanding, critical quality attributes, tech transfer attributes 
• Regulatory “ testing and validation protocols, submission of the simulation reports and outputs for the product files
• QA/QC- relevant certification and documentation 

Key Interactions (2/2)

External

• Working closely with Simulation tool providers, simulation experts on selection of the right code, program, tool etc. and its maintenance
• Academic bodies, regulatory notified bodies to keep simulation framework for Cipla up to date

Dimensions (1/2)

• 3-4 products at a time in the pipeline requiring simulations to solve glitches, optimization of design and manufacturability
• 1-2 critical products under approval/approved for non-clinical or abbreviated clinical approach with the global regulatory markets
• 1-2 standalone diagnostic products requiring simulation data for patient safety and efficacy demonstration to medical community

Dimensions (2/2)

Key Decisions (1/2)

Key Decisions (2/2)

Education Qualification

• Master™s degree in CFD/CAD-CAM, with bachelors in mechanical or chemical or electronics engineering.
• Certifications from ASME or ANSYS on simulation expertise highly welcome

Relevant Work Experience

• 2-3 years plus working proficiency on CFD, structural simulation platforms e.g. ANSYS
• Experience in design of simulation models, running simulation experiments independently
• In-depth knowledge of physics required for simulation of medical devices and the failure modes thereof
• Experience from leading medical device brands working on connected devices is highly welcome.