Director, Human Factors

Job Description

The Director, Human Factors plays a pivotal role in combination product development (both design and process), commercialization and lifecycle management. This person leads the Human Factors team to perform and manage human factors activities to ensure compliance with US and global regulatory policies/guidance for all combination products and medical devices in our company's portfolio and pipeline including acquisition products.

This Director position will interact extensively with all subject-matter experts within the Device Development team as well as with members of numerous internal cross-functional product development teams from concept through product launch and post market surveillance.

Key Responsibilities and Activities:

The Director, Human Factors is responsible for expanding and managing a Human Factors team that apply knowledge of human performance (perceptual, cognitive, and motor skills) and Human Factors techniques to a wide range of systems’ issues, across the product lifecycle: including customer needs identification, early product device concept selection/screening, user profiles, task analysis, user interface design, use error analysis, risk assessment and mitigation, usability testing, hazard analysis, and post-launch outcomes analysis.

The Human Factors director is expected to guide his/her team to:

• Perform and manage human factors activities throughout the whole product design and development cycle within the constraints of a regulated environment, including creating human factors plan, working with other disciplines to identify customer needs, intended use and potential hazard/harm, providing product and packaging design inputs/requirements, performing task analysis and use error analysis, designing instructions for use, conducting formative/summative studies, preparing regulatory submission materials, addressing post market surveillance and training need.

• Strategic planning of HF assessment for innovative product design

• Collaborate with cross-functional colleagues to create innovative and intuitive-to-use products and ensure regulatory compliance through risk management. The cross functional team includes marketing, product planning/project managing, formulation development, clinical, safety, regulatory, purchasing, manufacturing, packaging and labeling.

• Responsible for key development deliverable documents, ensure the management and maintenance of documents, records and databases that support regulatory compliance (such as human factors study protocol and report, Task analysis and use error analysis document etc)

• Stay up-to-date with the latest advancements in human factors within the regulatory and industry landscape and have the ability to represent our company in external communities and exert influence.

• Support other quality and GMP compliance activities relating to combination products and medical devices

• Perform other job related duties or special projects as required.

Minimum education required:

• B.A./B.S in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology, Engineering, Chemistry or Business Management plus 10 years of related experience

Required experience and skills:

• Minimum of 10 years of relevant experience, strong knowledge of human factors, device regulatory requirements and industry standards related to device systems.

• Proven experience in team and people management

• Excellent communication, leadership, and problem-solving skills.

• Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively.

PSCS

Current Employees apply HERE

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

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