Director, Human Factors

Job Description

The Human Factors director 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 Companys portfolio and pipeline including acquisition products.

This 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 Human Factors director 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.

• 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.

Qualifications:

• B.A./B.S. in Human Factors Ergonomics Cognitive or Experimental Psychology Sociology Engineering Chemistry or Business Management plus 15 years of related 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.

Required Skills:

Preferred Skills:

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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 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 salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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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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