Senior Manager - Disposables Product Development

TERUMO BCT, INC; Thiruvananthapuram; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Terumo Blood and Cell Technologies, located at Terumo Penpol in Thiruvananthapuram, India, seeks a senior engineer to lead disposables/materials development. You will guide a team of engineers on medical grade plastics, biocompatible materials and design controls while aligning with ISO/QMS/regulatory needs.

You will work across functions with Marketing and Manufacturing to drive new ideas, manage risks, and optimize manufacturability and cost.

Qualifications

• Bachelor’s or Master’s in Polymer Science/Plastics Engineering or related disciplines with plastics/disposables exposure; PhD preferred.
• Or engineering with proven design and development in regulated medical disposables/materials; PhD preferred.
• 10+ years plastics/polymer materials and product development experience; 5+ years in medical devices or regulated industry.

Responsibilities

• Drive disposables product development including application and development of innovative medical grade materials.
• Lead a team of engineers to achieve disposables development goals with strong motivation.
• Ensure compliance with ISO, QMS, design controls, and regulatory requirements.
• Coordinate with Marketing, Manufacturing, customers and vendors to support new ideas.
• Identify gaps, drive best practices and process improvements across projects.
• Manage project risks and assess manufacturability and cost effectiveness of designs.

Skills

Polymer materials

Plastics processing

Biocompatible materials

Design Controls

Quality Management System

Project leadership

Team development

Education

Polymer Science / Plastics Engineering (Bachelors or Masters)

Related engineering with plastics/ disposables focus

Job description

Location: Thiruvananthapuram, IN

At Terumo Blood and Cell Technologies, our 8,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential.

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.

• 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.
• Assess 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 relateddisciplines 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.

Terumo Penpol is part of Terumo Group and is headquartered in Thiruvananthapuram, Kerala. As India’s largest blood bag manufacturer, we provide a comprehensiverange of blood collection, storage and processing solutions for blood centers, hospitals and therapeutic apheresis centers in India and abroad. Our high-quality products touch the lives of patients in over 80 countries across the world.

True to our mission of contributing to society through healthcare, our award-winning Corporate Social Responsibility initiatives reinforce our organizational values and culture. Firmly rooted in core values collectively termed as the ‘Associate Spirit’, our work culture fosters an environment conducive to growth and continuous learning. People are our greatest asset, and we place as much importance in their professional development as in the research and development of our products.

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