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Human Factors Engineer

Date: Jan 12, 2019

Location: Waterford, IE, X19

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth!

Job Description

We would like to invite applications for the role of Human Factors Engineer at our Waterford site.  As a Human Factors Engineer in the Device Engineering team, you will drive the Human Factors aspects of inhalation development projects. You will apply your knowledge of the relevant regulations, directives, guidelines and standards to the development of medical devices and combination products. Your Human Factors knowledge will be applied to design and to evaluate products, and to creatively solve complex problems. You will also use your experience of working with and supervising external suppliers and contractors on Human Factors activities. You will lead the HF tasks in multi-disciplinary projects to ensure that the regulatory requirements for Human Factors are met, as well as providing creative solutions to problems. You will also drive the development and maintenance of departmental processes and methods.

 

Key Responsibilities

  • Drive the human factors activities at various stages of development, from research through design, verification and validation, and into life-cycle management
  • Manage Teva’s Human Factors vendors to ensure that their output meets Human Factors best-practice and the requirements of Teva’s Quality Management System
  • Follow Human Factors processes and procedures according to regulations and best practice
  • Lead and implement changes to Teva’s HF processes and methods against regulations and best-practice
  • Lead and support use-related risk management activities and support other risk management activities.
  • Ensure compliance with Teva’s QMS
  • Collaborate internally and externally
  • Travel globally as required to support projects, up to approx. 20% of time out of the office.
  • Participate in regulatory audits
  • Author and review Human Factors documents for design history files
  • Educate internally and externally on Human Factors processes and topics

 

Skills and Abilities

  • Must have relevant industry experience in human factors
  • Training in Design Controls and Human Factors for medical devices
  • Capable of operating independently on human factors tasks. Uses initiative to identify further tasks or activities required to resolve problems
  • Detail-oriented and thorough in reviewing documents and designs
  • Analytical human factors assessments of devices, products, labelling and packaging
  • Ability to influence and educate, both internally and externally
  • Adaptable, cooperative and helpful attitude towards colleagues and customers
  • Analytical approach to understanding and solving problems
  • Enjoys working hard, is driven and able to challenge. Quickly seizes opportunities.
  • Can effectively cope with change, coping with risk and uncertainty while comfortably adapting to changing conditions
  • Liaises with different functions within Teva
  • Execution of Human Factors activities at all stages of device development, from research through design, verification, validation and life-cycle management
  • Good verbal and written communication including high quality human factors documentation.
  • Good presentation skills
  • Create and maintain documentation and design history in accordance with the company design and quality management systems
  • Keep abreast of competitors’ devices, related technology, reviewing industry specific journals and periodicals, attending conferences and university technology development

Qualifications

Knowledge

  • Human Factors standards, guidance and best practice
  • Understanding of device and drug/device regulatory requirements
  • Knowledge of GMP, EU and FDA regulatory requirements for Human Factors for Medical Devices and/or combination products
  • Understanding of consumer product design from concept to commercialization

 

Education

  • A bachelor’s degree preferably in Human Factors Engineering, Usability Engineering, Ergonomics, Psychology, Industrial Design or Engineering. Any other bachelor’s degree with relevant experience will also be acceptable

 

Competencies

  • Collaboration - The ability to work effectively with peers, partners and others, to positively impact performance
  • Planning & Organizing - Adopts a structured approach, establishes plans, priorities and goals that are clear and logical
  • Drive & Resilience - Demonstrates drive and persistence to meet and exceed objectives; remains positive in challenging situations and recovers quickly from setbacks
  • Effective Communication - Communicates clearly to others and ensures understanding.  Adjusts style of communication appropriately to the audience
  • Change & Adaptability - The ability to recognize and act upon change as a necessity to achieve goals
  • Analytical Thinking & Problem Solving - Analyses information effectively; identifies the causes of problems and provides realistic and practical solutions to address them
  • Customer Focus - Identifies and understands the customer’s needs.  Focuses on meeting their needs, ensuring both satisfaction and a continuing business relationship
  • Integrity - Maintains high standards of honesty and trustworthiness.  Considers ethical implications of issues and decisions

Function

Research & Development

Sub Function

Drug Development and Preclinical Studies

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.

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