The International Society for Pharmaceutical Engineering, Inc.
Senior Human Factors Engineer
The International Society for Pharmaceutical Engineering, Inc., Boston, Massachusetts, us, 02298
Do you have a passion for science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the place for you!At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.Summary of the group:The Human Factors Engineering Group provides human factors (HF) expertise and leads human factors engineering (HFE) work on device development project teams developing drug delivery systems. The Human Factors Engineer may support more senior Human Factors Engineers, and/or directly collaborate with cross functional teams, including device engineering, regulatory, quality, clinical, program management, and marketing, to develop drug device combination products and ensure these products are safe and effective for use.Main Duties & Responsibilities:The candidate will be responsible for the following activities:Developing HFE strategies and leading/supporting HF activities on drug delivery device technology development and/or drug-device combination product program teams from early-stage development to new product introduction and support for on-market products. This includes ethnography, requirements definition research, use-related risk analysis, formative usability studies, instruction and training development, and summative usability studies.
Authoring HF deliverables for device design history files. Writing HF sections for health authority submissions and written responses.
Interacting with other HF group members and senior leaders with regards to HF strategy and implementation.
Improving internal HFE processes at AstraZeneca to ensure consistency, compliance and efficiency
Education & Experience Requirements:Education:
Bachelor’s or Master’s Degree in human factors engineering, bioengineering, mechanical engineering, or related fieldExperience:Bachelor’s Degree and 10+ years of related experience with 3+ years of experience in applying human factors engineering to medical device or combination product development -OR- Master’s Degree and 8+ years of related experience with 3+ years of experience in applying human factors engineering to medical device or combination product development.Required Skills:Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidances for medical devices and combination products and how to integrate into end-to-end combination product development
Designing, planning, and implementing ethnographic, formative, or summative usability studies, with or without the support of external consultancies
Demonstrated ability to translate multiple inputs (e.g., study results, technical constraints, etc.) into user needs and/or design recommendations
Proven ability to collaborate actively and proactively with others cross-functionally, particularly to champion initiatives or establish processes, with strong interpersonal skills
High level of initiative and ability to work independently
Ability to analyze data, including knowledge and proficiency with basic statistics
Desired Skills:Ability to communicate effectively in writing, verbally, and as a presenter
Demonstrated time management, critical thinking, decision-making, and organization skills
Complex problem-solving, root cause investigation, and technical development methodologies
Experience with development of promotional instructional materials and patient support programs for new product introductions and on-market product support based on understanding of the patient journey and passion to improve the experience with our products
Working knowledge of periodic risk review and change control processes for on-market drug-device combination products
Ability to adapt to a rapidly changing environment
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Authoring HF deliverables for device design history files. Writing HF sections for health authority submissions and written responses.
Interacting with other HF group members and senior leaders with regards to HF strategy and implementation.
Improving internal HFE processes at AstraZeneca to ensure consistency, compliance and efficiency
Education & Experience Requirements:Education:
Bachelor’s or Master’s Degree in human factors engineering, bioengineering, mechanical engineering, or related fieldExperience:Bachelor’s Degree and 10+ years of related experience with 3+ years of experience in applying human factors engineering to medical device or combination product development -OR- Master’s Degree and 8+ years of related experience with 3+ years of experience in applying human factors engineering to medical device or combination product development.Required Skills:Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidances for medical devices and combination products and how to integrate into end-to-end combination product development
Designing, planning, and implementing ethnographic, formative, or summative usability studies, with or without the support of external consultancies
Demonstrated ability to translate multiple inputs (e.g., study results, technical constraints, etc.) into user needs and/or design recommendations
Proven ability to collaborate actively and proactively with others cross-functionally, particularly to champion initiatives or establish processes, with strong interpersonal skills
High level of initiative and ability to work independently
Ability to analyze data, including knowledge and proficiency with basic statistics
Desired Skills:Ability to communicate effectively in writing, verbally, and as a presenter
Demonstrated time management, critical thinking, decision-making, and organization skills
Complex problem-solving, root cause investigation, and technical development methodologies
Experience with development of promotional instructional materials and patient support programs for new product introductions and on-market product support based on understanding of the patient journey and passion to improve the experience with our products
Working knowledge of periodic risk review and change control processes for on-market drug-device combination products
Ability to adapt to a rapidly changing environment
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