Human Factors Engineer Jobs

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 Client to ensure consistency, compliance and efficiency

Education & Experience Requirements:

Degree in human factors engineering, bioengineering, mechanical engineering, or related discipline. Years of required experience will vary based on the highest level of education completed, the level of expertise within combination products.

Engineer: Bachelor’s Degree and a minimum 5 years of related experience or Master’s Degree and a minimum of 2 years of related experience in applying human factors engineering to medical device or combination product development

Sr. Engineer: Bachelor’s Degree and a minimum of 10 years of related experience with at least 3 years of experience in applying human factors engineering to medical device or combination product development -OR- Master’s Degree and a minimum of 8 years of related experience with at least 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 executing 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