Principal Scientist, Human Factors

Socket.dev; Rahway (NJ); On-site; USD 157,000 - 247,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Socket.dev seeks a senior Human Factors leader to guide a team of scientists through the development of combination products and medical devices, from concept to post-market surveillance.

You will collaborate with Device Development and multiple cross-functional teams to ensure usability, risk management, and regulatory submissions while mentoring staff in a fast-paced, hybrid environment.

Qualifications

• B.A./B.S in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology, Engineering, Chemistry, or Business Management plus 10 years of related experience.
• Strong knowledge of human factors, device regulatory requirements, and industry standards related to device systems.
• Prefer to have 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.

Responsibilities

• Lead a Human Factors team applying knowledge of human performance to a wide range of systems’ issues across the product lifecycle.
• Coach and mentor junior scientists, fostering their professional growth and development.
• Perform and manage human factors activities throughout the product design and development cycle in a regulated environment, including creating plans, identifying customer needs, intended use, and hazards, providing inputs, performing analyses, designing instructions, conducting studies, preparing regulatory materials, and addressing post-market surveillance.
• Strategic planning of HF assessment for innovative product design.
• Collaborate with cross-functional colleagues to ensure regulatory compliance through risk management; team includes marketing, product planning, formulation development, clinical, safety, regulatory, purchasing, manufacturing, packaging, and labeling.

Skills

Adaptability

Combination Products

Data Analysis

FEA

Innovative Thinking

Leadership Mentoring

Pharma Process Dev

Professional Collaboration

Professional Networking

Quality by Design

Regulatory Filings

Strategic Thinking

Technology Transfer

Education

B.A./B.S in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology, Engineering, Chemistry, or Business Management

Job description

Job Description

The Human Factors team plays a pivotal role in combination product development (both design and process), commercialization, and lifecycle management. This person will lead several Human Factors scientists 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 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 Principal Scientist is responsible for managing a Human Factors team that applies 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.
• Coach and mentor junior scientists, fostering their professional growth and development within the organization.
• 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 plans, 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 needs.
• 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 management, formulation development, clinical, safety, regulatory, purchasing, manufacturing, packaging, and labeling.
• Responsible for key development deliverable documents, ensuring 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 documents, 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 10 years of related experience.
• Strong knowledge of human factors, device regulatory requirements, and industry standards related to device systems.
• Prefer to have 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.

#EligibleforERP

Required Skills:

• Adaptability
• Combination Products
• Data Analysis
• Finite Element Analysis (FEA)
• Innovative Thinking
• Leadership Mentoring
• Pharmaceutical Process Development
• Professional Collaboration
• Professional Networking
• Quality by Design
• Regulatory Filings
• Strategic Thinking
• Technology Transfer

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.

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

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/26/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

The salary range for this role is

$156,900.00 - $247,000.00

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 employee’s 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 https://jobs.merck.com/us/en/compensation-and-benefits.