Human Factors Engineer
HUMAN FACTORS ENGINEERGAITHERSBURG, MD Location South San Francisco Preferred, Gaithersburg MD secondary (position will start off remote and expected to transition to an onsite role once COVID restrictions are lifted at sites).
Project Description:
The successful candidate will provide human factors expertise and lead human factors engineering work on device development project teams developing drug delivery devices.
The Human Factors Engineer will collaborate with these cross functional teams, including device engineering, regulatory, quality, clinical, program management, and marketing, to guide development of combination drug device products and ensure these products are safe and effective for use.
Major Duties and
Responsibilities:
The candidate will be responsible for the following activities:
Developing human factors engineering strategies and leading HF activities on drug-device combination product program teams, including ethnography, requirements definition research, use-related risk analysis, formative usability studies, instruction and training development, and summative usability studies.
Writing and reviewing HF sections for health authority submissions.
Interacting with health authorities during face to face meetings and in written responses.
Interacting with senior leaders with regards to HF strategy and implementation.
Improving internal Human Factors processes at the Client to ensure consistency, compliance and efficiency.
Required Skills:
Education:
Degree in human factors engineering, bioengineering, mechanical engineering, or related discipline.
BS and a minimum of 5 years of related experience or MS and a minimum of 3 years of related experience.
Experience:
The right candidate will have 5
years' experience in applying Human Factors engineering to medical device or combination product development.
Years of required experience will vary based on the highest level of education completed, the level of expertise within combination products and the level of position being interviewed for.
Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidance's for medical devices and combination products.
Experience working cross-functionally on risk management activities.
Proven ability to clearly communicate how study results can be implemented into design.
Experience working with external consultancies, or as part of an external consultancy team that supported the design and development of new medical devices.
Ability to analyze data, including knowledge and proficiency with basic statistics Other Skills and
Qualifications:
Ability to communicate effectively in writing, verbally, and as a presenter.
Demonstrated tie management, decision making, presentation, and organization skills.
Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team.
High level of initiative and ability to work independently.
This 12
month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Karen:
karen@alphaconsulting.
com ALPHA'S REQUIREMENT #20-01403W2 ONLY MUST BE ELIGIBLE TO WORK IN THE US AS AN HOURLY W2 EMPLOYEE.
Estimated Salary: $20 to $28 per hour based on qualifications.
Project Description:
The successful candidate will provide human factors expertise and lead human factors engineering work on device development project teams developing drug delivery devices.
The Human Factors Engineer will collaborate with these cross functional teams, including device engineering, regulatory, quality, clinical, program management, and marketing, to guide development of combination drug device products and ensure these products are safe and effective for use.
Major Duties and
Responsibilities:
The candidate will be responsible for the following activities:
Developing human factors engineering strategies and leading HF activities on drug-device combination product program teams, including ethnography, requirements definition research, use-related risk analysis, formative usability studies, instruction and training development, and summative usability studies.
Writing and reviewing HF sections for health authority submissions.
Interacting with health authorities during face to face meetings and in written responses.
Interacting with senior leaders with regards to HF strategy and implementation.
Improving internal Human Factors processes at the Client to ensure consistency, compliance and efficiency.
Required Skills:
Education:
Degree in human factors engineering, bioengineering, mechanical engineering, or related discipline.
BS and a minimum of 5 years of related experience or MS and a minimum of 3 years of related experience.
Experience:
The right candidate will have 5
years' experience in applying Human Factors engineering to medical device or combination product development.
Years of required experience will vary based on the highest level of education completed, the level of expertise within combination products and the level of position being interviewed for.
Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidance's for medical devices and combination products.
Experience working cross-functionally on risk management activities.
Proven ability to clearly communicate how study results can be implemented into design.
Experience working with external consultancies, or as part of an external consultancy team that supported the design and development of new medical devices.
Ability to analyze data, including knowledge and proficiency with basic statistics Other Skills and
Qualifications:
Ability to communicate effectively in writing, verbally, and as a presenter.
Demonstrated tie management, decision making, presentation, and organization skills.
Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team.
High level of initiative and ability to work independently.
This 12
month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Karen:
karen@alphaconsulting.
com ALPHA'S REQUIREMENT #20-01403W2 ONLY MUST BE ELIGIBLE TO WORK IN THE US AS AN HOURLY W2 EMPLOYEE.
Estimated Salary: $20 to $28 per hour based on qualifications.
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