09 Sep
|
Artech
|
Thiruvananthapuram
09 Sep
Artech
Thiruvananthapuram
JOB TITLE: New Product Development
JOB SUMMARY
Responsible for planning and execution of disposables product and materials development. To be a subject matter expert for medical disposable product development, biocompatible materials development and processing to execute various disposables development projects. To lead a team of engineers with high level of passion and motivation to achieve goals.
Experience
▪ Minimum 10 years of progressive experience in Plastics/Polymer materials, processes and product development in an advanced research & development facility /similar.
▪ Minimum of 5 years medical device industry or equivalently regulated industry.
Skills ▪ Exceptional understanding of technology and methods including material development and selection, design & development, manufacture and quality.
▪ Knowledge of Plastics product design, Processing, Mould/Tool development
▪ In-depth knowledge of Biocompatible materials development and their application.
▪ Experience in plastics materials formulation, test methods and their qualification preferably in PVC.
▪ Understanding and application of Design Controls and Quality Management System to product development.
▪ Knowledge of business and management and coordination with people and other resources.
▪ Drive end to end product lifecycle management with proficiency in applicable tools.
▪ Well versed with medical device regulatory requirements.
▪ Knowledge of current FDA regulatory and ISO requirements and trends affecting medical devices. ▪ Must be detail oriented, well organized and able to work independently and in teams.
▪ Possess a strong commitment to company values, solid champion of team work , continuous improvement etc.
▪ Advanced understanding and application of Design Controls, Quality Management System to product development.
▪ Sufficient knowledge in disposables aging, standard testing, test methods and pharmaceutical solution development etc.,
Essential Duties
▪ Drive disposables product development including application and development of innovative medical grade materials.
▪ Plastic materials subject matter expert contributing to the development and application of new proprietary plastic materials and processes for disposable medical products.
▪ Evaluates proposed solutions, adaptations, and modifications to products used globally through technical and managerial expertise.
▪ Ensure compliance with all ISO product and QMS standards, product documentation, specifications, SOPs and regulatory requirements, and safe working practices.
▪ Effectively utilize resources and manage activities within budget as per functional cost centres.
▪ Works across diverse regional and functional boundaries to promote collaboration and teamwork.
▪ Communicates on all levels with senior management, including technical, strategic, and business. ▪ Partner with Marketing team and Manufacturing team, customers and vendors to support new creative ideas in the area of disposables / materials development.
▪ Responsible for the training and development of teammates for improving knowledge and skill levels – Continuously.
▪ Manages direct report project leaders, technical supervisors, and engineers.
▪ Identifies gaps and develops best practices and process improvements for project or functional area.
▪ Coordinate with representatives from the Quality organization to identify requirements and ensure strict compliance with Design Control procedures
▪ Responsible for identification, mitigation and communicating project risk management activities. ▪ Assesses the overall manufacturability of new designs in terms of manufacturing efficiency and cost effectiveness.
MINIMUM QUALIFICATION REQUIREMENTS Education ▪ Bachelor’s or Master’s degree in Polymer Science /Plastics Engineering/or other related disciplines with significant exposure to plastics/disposables development; preferably with PhD.
📌 New Product Development (10+ Years) (Thiruvananthapuram)
🏢 Artech
📍 Thiruvananthapuram