Human Factors/Risk Management Engineer (m/f)
Human Factors/Risk Management Engineer (m/f), Global Drug Development, Kundl/Schaftenau, Austria
3 is the maximum number of steps that a user accepts to do when using an injection device! Intuitive steps are key for the safety! Designing simple devices is key for safety and efficacy! We are seeking a Human Factors/Risk Management Engineer to lead human factors and risk management activities in developing bio-similar medical devices from early concept phase over late phase development to lifecycle management. This position is part of multidisciplinary and international development teams.
Your responsibilities include to independently implement the Human Factors and Risk Management strategy into multiple projects.
• User needs identification, development of user profiles and use scenarios, task analysis, inform design decision to insure user friendly device design, perform comparative analysis, support Health Authority communication, user interface specification
• Develop and design instructions for use, in compliance with both company quality assurance standards and applicable regulations
• Provide expertise in a broader cross-functional development
• Author and review in particular risk management plan, hazard identification, use related risk analysis, system, design and process risk analyses, risk management report
• Coordinate the required technical experts for risk assessment workshops
• Communicate Human Factors and device risk related challenges and project risks to design team/cross functional team and provide design recommendations
• Establish Human Factors and risk management best practice, apply Human Factors and risk management best practice and share lessons learned
• Your communication and negotiation skills will be key to influence multiple stakeholders
• Your management skills will be key to plan and deliver according to the required time lines
• Support definition of internal procedures and templates to facilitate the execution of human factors engineering and risk management activities.
• You will work independently against self-set targets.
What you’ll bring to the role:
• Bachelor’s or Master degree in engineering, ergonomics, psychology, human factors, usability, user interface design, industrial design/graphic design or related discipline.
• Excellent skills in English, verbal and written are required. Other language skills, in particular in German are advantageous.
• An ideal candidate would have a relevant degree and 5 years of experience in applying Human Factors Engineering/usability or Risk Management to medical devices development, preferably in the pharmaceutical industry, including: Good understanding and specific knowledge on applying Human Factors Engineering or Risk Management processes to medical device development from concept generation to health authority submission
• Experience in project management
• Good understanding of the risk management activities
• May require up to 15% travel
Why consider Novartis?
799 million. That’s how many lives our products touched,. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 50.374,38 per year on a full time basis).
Imagine what you could do at Novartis!
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.