Senior Human Factors Engineer
AstraZeneca Göteborg / Apotekarjobb / Mölndal
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AstraZeneca is now looking to hire a Senior Human Factors Engineer within Pharmaceutical Technology and Development. Placement for the role is at our site in Gothenburg, Sweden.
Pharmaceutical Technology and Development (PTD) is the bridge that turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices for new medicines and providing expert technical support to all AZ's commercial drug substances and products to ensure we successfully supply medicines to patients.
Manufacturing Science and Technology provides Product Robustness (data analytics, validation strategy and product knowledge management), Technology Strategy and Process Engineering, and second line On Market Technical Support.
Main Duties and Responsibilities
As Senior Human Factors Engineer, you are responsible for ensuring application of human factors /usability engineering in the design and development of medical device and combination products. Core responsibilities include defining user needs, conducting usability evaluation and driving improvements to the use interface of medical devices. The ideal candidate is well versed in user-centered design principals, has a deep understanding of medical device development and regulation, and can work independently with minimal direct supervision.
The Senior Human Factors Engineer will:
• Define user needs and human factors requirements, design formative and summative usability studies, oversee execution of studies, and preparation of reports. Clearly communicate how study results can be implemented into design.
• Make recommendations and negotiate design improvements to mitigate use errors and improve usability.
• Create, update and maintain user-interface requirements documents with a clear trace between use risks, mitigation and validation test cases
• Design instructions for use (IFU) documents and training materials for medical devices. Prepare and review human factors summaries for regulatory submissions.
• Write formative and summative usability study protocols and summary reports consistent with health authority expectations
• Analyze complaints from on-market products and update usability risk assessment, escalate usability-related issues as necessary with recommendations for remediation.
• Keep abreast of regulations and best practices for medical device human factors and advise management on improvements to internal processes and regulatory issues related to Human factors engineering.
• Lead, co-ordinate and manage timely delivery of contracted HF services
Essential Requirements
• BS Degree in Mechanical Engineering, or Biomedical engineering. Graduate degree preferred. A minimum of 8 years' work experience with an MS and 12 years with a BS in medical device development
• Understanding of FDA and EU regulation in medical device and combination products (CFR 820.30 Design Controls and risk assessment per ISO 14971 and ISO 14971, FDA Human Factors regulations, standards and guidance for medical devices, combination products and pharmaceutical packaging/labelling; 4) Injectable combination products) and experience in developing products under these guidelines
• Strong interpersonal skills and excellent oral and written communication skills.
Desirable Requirements
• Familiarity with web and mobile standards and technologies
If interested, apply now!
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertise
Publiceringsdatum2018-06-28Så ansöker duSista dag att ansöka är 2018-07-13
Klicka på denna länk för att göra din ansökanFöretagAstraZeneca Göteborg
KontorsadressPEPPAREDSLEDEN 1
Jobbnummer 4227465
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