13 days old

Senior Human Factors Engineer

Pfizer
Columbia, MD
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**ROLE RESPONSIBILITIES**



+ Generate and ensure approval of all device human factors engineering documentation for assigned projects

+ Perform task analysis and use error assessment to identify critical and essential tasks. Provide input into risk management activities for assigned projects ensuring risk files are aligned with human factors activity and feedback

+ Provide device usability input/support to device design inputs and device design specification

+ Generate Human Factors and Design Validation objectives and deliverables plan, and documents goals and strategies within a Design Validation and HF plan

+ Manage all human factors (HF) activities associated with HF vendors, including on boarding of HF vendor, generation of study brief, attainment of HF vendor proposals, assignment of HF vendor, providing all relevant materials and documentation, management of HF studies, and generation and approval of associated reports

+ Project manage the supply, assembly and testing of materials for use in HF studies and associated documentation

+ Report any adverse findings or adverse events witnessed at HF studies and ensure appropriate action

+ Ensure timely execution of HF studies for assigned projects

+ Provide HF study feedback and/or recommended mitigation actions into the project Core Team

+ Provide input and support for generation of assigned Pfizer device Instructions for Use (IFU), device labelling and packaging

+ Design and ensure full change control for IFU documentation where applicable for assigned projects

+ Ensure work is done in compliance to design control regulations and company policies and procedures

+ Support the generation of device regulatory submission data. Ensure high quality deliverables in compliance with Regulation and local procedures.

+ Assist in the application of HF engineering principles and controls for all device development projects

+ Support and conduct human factors research to augment present and future device projects including in-house laboratory testing and external research with the support of contract staff/vendors

+ Support internal and external audits of HF related aspects of the Quality System



**BASIC QUALIFICATIONS**



+ B.S. Degree in human factors engineering, experimental psychology, cognitive psychology, industrial design or a related field with 5 - 7 years experience

+ M.S Degree in one of the above disciplines 3 - 5years experience

+ Ph.D. in Engineering discipline with 1 - 3 years experience



(Biomedical Engineering or Mechanical Engineering preferred for second or third degree)



**PREFERRED QUALIFICATIONS**



+ Human factors and usability engineering

+ Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.

+ Strong mathematical, analytical, and reasoning skills

+ Strong problem solving skills

+ Strong innovation skills

+ Strong creativity astuteness

+ Strong research skills

+ Strong organizational skills

+ Strong in team work

+ Strong written and oral communication

+ Experience in complying with FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30 and EU Medical Device Directives

+ Ability to prioritize multiple responsibilities and to work on multiple projects simultaneously

+ Responds to requests for service and assistance with professionalism, courtesy, and confidence



**PHYSICAL/MENTAL REQUIREMENTS**



The employee is regularly required to sit, talk or hear, stand and walk. Lifting boxes of 20 lbs. Specific vision abilities required by this job include ability to adjust focus. The noise level in the work environment is usually moderate.



**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**



+ Must be able to travel 25% - 35% of the time.

+ Position requires regular onsite attendance, however, this position may be performed on a remote or telecommute basis on a temporary, short term basis.

+ Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

+ Must have the ability to work effectively under and manage to strict production, time and performance deadlines.

+ Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays.



**ORGANIZATIONAL RELATIONSHIPS**



+ Director of Biomedical Technology

+ Senior Director of Biomedical Technology

+ Associate Biomedical Engineers, Biomedical Engineers, and Principal Biomedical Engineers

+ Cross-functional teams of various disciplines within Pfizer/Meridian

+ CROs as required

+ Works within multi-disciplinary teams within Meridian Medical Technologies (MMT).

+ Interfaces with core teams within MMT, Regulatory and QA groups, Pfizer Global Supply (PGS), Pfizer Commercial, Pfizer clinical groups and other groups within Pfizer involved in device development.

+ Interfaces with external Human Factors suppliers and customers.



**Supervision**



May oversee engineering work conducted by Associate Biomedical and Biomedical Engineers

May also provide training for new hires or contractors and may oversee work conducted by contractors or lab technicians.



**ROLE SUMMARY**

This role's primary purpose is for ensuring that assigned devices, associated labeling and packaging, and training (if applicable) are designed to be safe and effective for use by intended users within intended environments for all chosen markets. As part of the product development teams, this role will be accountable to work with external design companies and human factors vendors in developing and ensuring timely execution of human factors engineering deliverables for assigned devices. Performs human factors (usability studies), market assessment, or pre-clinical research. Responsible for adhering to design controls and documenting all product development work in a Design History File.



**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment.



The job is open only to Protected Individuals (as defined by 8 U.S.C. 1324b(a)(3), namely, Citizens or Nationals of the United States, Lawful Permanent Residents ("green card holders"), Refugees and Asylees.



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



**Other Job Details:**



+ **Last Date to Apply for Job: November 15, 2018** Eligible for Relocation Package



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Posted: 2018-11-02 Expires: 2018-12-03

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Senior Human Factors Engineer

Pfizer
Columbia, MD

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