Senior Human Factors Engineer
2 weeks ago
Haemonetics is committed to the protection of personal data in accordance with applicable laws and regulations.
The editor and data controller ofwww.haemonetics.com is Haemonetics Corporation, 125 Summer Street, Boston, Massachusetts, 02110 U.S.A. The global Data Privacy Officer of Haemonetics can be reached at this address.
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Senior Human Factors Engineer
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locations
Boston, MA, US
time type
Full time
posted on
Posted 6 Days Ago
job requisition id
R8219
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further Haemonetics is your employer of choice.
Job Details
Job 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 SOPs that are compliance to applicable standards and guidance
SUPERVISORY RESPONSIBILITIES :
Carries out supervisory responsibilities in accordance with the organizations 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
Throughout our history, we have earned a solid reputation for product innovation, technical expertise, and operational excellence. Today, our products, internal research and development, marketing partnerships, and product acquisitions reflect our unwavering commitment to provide safe and available blood for patient transfusions and for use in pharmaceuticals.We rely on our talented global workforce to help us achieve our mission of providing innovative medical devices that advance the safety, quality, and availability of the world's blood supply. To achieve our business goals and objectives, we are committed to attracting and retaining the best and brightest talent while offering a challenging, dynamic, and exciting work environment that offers professional growth and development.
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