Human Factors Specialist
Posted on 20/04/17
Come Join Us
Position: Human Factors Specialist Contract: Permanent Location: Sandwich, UK or Dublin, Ireland Company: Global Device Development
For Us, It’s a Mission
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership.
Our Global Device Development organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery of our large and growing range of generic and branded products around the globe.
The technologies we develop enable drug-delivery for respiratory, biologic, biosimilar and injectable products, and we work across Mylan to support innovative technology solutions to deliver healthcare to our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time.
Make a Difference
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role.
An exciting opportunity has arisen to support the Mylan Global Device Development Group who are Responsible for the development of human factors strategies, execution of non-clinical human factors programs and user-focussed risk assessment across Mylan’s device and combination product portfolio.
- Define bespoke HF strategy and program for multiple Medical Device or Drug-Device Combination Product programs in line with global regulatory requirements, guidance’s and latest regulatory and industry thinking.
- Develop human factors programs, conducting appropriate development and validation studies at key stages during the device development program.
- Linking to clinical, regulatory and labelling teams as appropriate throughout the program.
- Ensure that the HF program is integrated and current within the overall project plan.
- Develop User-related design input requirements and lead User-focussed Risk Assessment activities in collaboration with the Risk Management lead.
- Develop and execute the design validation plan within device design controls and Quality Management Systems.
- Ensure that the output of human factors studies are fed into the on-going device design and development program, development of Instructions for Use and Risk Management Plans.
- Report on HF status through device design reviews and overall product risk assessments.
- Ensure awareness of competitor/reference device products in relation to development of human factors programs, including gap analyses for user-related tasks and functionality
Make Our Values Your Values
Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude.
People who are leaders and now that by working together we can run faster, reach higher and achieve more.
By doing so, we will continue to set new standards in healthcare. Here are the minimum qualifications for this position:
- Demonstrable experience of working under device design controls specifically in the area of Human Factors / Usability Engineering / User-focussed Risk Management
- Strategic thinking
- Experienced in ISO/FDA requirements as applicable to device design and regulatory labelling.
- Experience in the development of Combination Products/ Drug Device Systems within the pharmaceutical industry.
- Experience of Design Iteration and Applied Design.
- Knowledge of graphic design and associated software packages.
- Appropriate Science, Engineering or Psychology Degree.
- Travel within Europe & US appropriate to project requirements, averaging 20% of working year.
- Regular travel between the Dublin, Cambridge (UK) and Sandwich (UK) sites.
- Excellent communicator; clear and concise in communications with internal and external partners.
- Ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals.
- Attention to detail in working approach.
- Strong team player that is willing to take on and support other activities outside core expertise as required to develop the future of the department.
If you want to be a part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care. Mylan is an Equal Opportunity Employer.
To submit your application, please visit www.mylan.com/careers and select UK - you will then need to create a candidate profile to apply for the position. Requisition ID: 17000577
Closing date for applications: Friday 2nd June 2017.