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Job DetailsJob Title:
Senior Human Factors Engineer
Research & Development
JOB SUMMARY
Responsible for being the subject matter expert for human factors engineering across process, principles, usability, validation testing methods. Leading product requirement development by applying user centered design and development methods. Lead user and customer usability, formative usability studies, and usability validation studies. Translates outcomes of studies into product requirements, technical documentation and specifications.
ESSENTIAL DUTIES
Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Enter Responsibilities/Essential Duties:
- Conducting human factors analyses, summative and formative usability studies. Owns protocol design, study execution, data collection, report creation and review/release
- Investigates and defines usability requirements for product requirements that address human factors engineering process and appropriately mitigate use related risks
- Expert in relevant usability standards and risk management such as IEC 62366-1, ANSI HE75, ISO 14971 and FDA guidance
- Contributes to the design development process by participating in design review meetings, reviewing, and contributing to design inputs, risk analysis, and reviewing and testing new product performance.
- Responsible for HF assessments included in regulatory documents
- Develop and Maintain SOP's that are compliance to applicable standards and guidance
SUPERVISORY RESPONSIBILITIES:
Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, training employees; planning, assigning and directing work; addressing complaints and resolving problems.
EDUCATION Required:
Bachelor's Degree
Human Factors Engineering / Systems Engineering
EXPERIENCE:
Required 5 years
In human factors engineering for a medical device or highly regulated industry
Required
Other:
Experience developing and leading Formative and Summative usability
Working with test management tools such as DOORS,
Rational Quality Manager and Rational team Concept
EEO Policy Statement
Haemonetics is an equal opportunity employer. In accordance with applicable law, we prohibit discrimination against any applicant or employee based on any legally-recognized basis, including, but not limited to: race, color, religion, sex (including pregnancy, lactation, childbirth or related medical conditions), sexual orientation, gender identity, age (40 and over), national origin or ancestry, physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed service member status or any other status protected by federal, state or local law (“Protected Characteristic”). Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee, including managers and co-workers.