Manager - Disposables Product Development

JOB TITLE:Manager-Disposables Product Development

JOB SUMMARY

Responsible for planning and execution of disposables product and materials development for Terumo BCT located at Terumo Penpol site in Trivandrum India.

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.

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

• Bachelors or Master’s degree in Polymer Science /Plastics Engineering/or other related disciplines with significant exposure to plastics/disposables development; preferably with PhD.

-Or-

• Bachelor’s or Master’s degree in related engineering field with strong track record of design and development experience in highly regulated medical device disposables/materials/plastics engineering domains; preferably with PhD.

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, strong 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.,

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential duties.

Additional Physical Requirements

Requires travel based on business needs.