Merck & Co, Inc

Senior Scientist, Drug/Device Combo Products (Hybrid)

Merck & Co, Inc • $117K — $184K *
West Point, PA 19486Hybrid
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • B.A./B.S. in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology, or M.A./M.S. in a relevant discipline.
  • Strong knowledge of human factors and device regulatory requirements.
  • Experience in team and people coaching is preferred.
  • Excellent communication and leadership skills.
  • Ability to effectively manage multiple priorities in a fast-paced environment.

Responsibilities

  • Lead human factors activities throughout product development in a regulated environment.
  • Create human factors plans and identify customer needs and potential hazards.
  • Integrate human factors into cross-functional collaborations for regulatory compliance.
  • Maintain records and databases supporting regulatory compliance with cross-functional colleagues.
  • Lead delivery of regulatory documents, including protocols and reports for submissions.
  • Conduct scientific literature reviews to support human factors research.
  • Undertake special projects and additional job-related duties as needed.

Benefits

  • Hybrid work arrangement for flexibility.
  • Opportunity to collaborate with diverse teams and experts.
  • Engagement with cutting-edge technologies in human factors.
  • Exposure to all phases of product lifecycle from design to post-market surveillance.
  • Potential for career growth through coaching and leadership opportunities.
Full Job Description

Job Description

Senior Scientist, Human Factors

The Human Factors team plays a pivotal role in combination product development (both design and process), commercialization, and lifecycle management. This person will lead 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 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. The Senior Scientist in this role will be responsible for performing and managing human factors activities to ensure compliance with US and global regulatory policies/guidance for all combination products.

Key Responsibilities and Activities:

  • 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 and use error analysis, designing instructions for use, conducting formative/summative studies, preparing regulatory submission materials, addressing post market surveillance and training need.
  • Partner with marketing, program management, clinical, safety, regulatory, manufacturing, packaging, and labeling to integrate HF, manage risk and ensure regulatory compliance
  • In collaboration with cross-functional colleagues, ensure the management and maintenance of records and databases that support regulatory compliance
  • Collaborate cross- functionally to support and maintain the internal HFE processes  to ensure consistency, efficiency and compliance
  • Lead regulatory deliverables: HF protocols/reports, linkage to risk management (ISO 14971), hazard/use-related risk analyses, and submission materials (FDA, EU MDR).
  • Perform scientific literature reviews and database research on various topics independently and synthesize relevant information in support of  the human factors research Perform other job related duties or special projects as required.

Qualifications:

  • B.A./B.S in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology plus three years of related experience or M.A/M.S. in one of the above disciplines.
  • Strong knowledge of human factors, device regulatory requirements, and industry standards related to device systems.
  • Prefer to have experience in team and people coaching.
  • Excellent communication, leadership, and problem-solving skills.
  • Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively.

# eligibleforERP

#PRD

Required Skills:

Analytical Method Development, Creativity, Data Compliance, Geometric Dimensioning And Tolerancing (GD&T), ISO 13485 Medical Devices, Manufacturing Processes, Mechanical Design, Mechanical Testing, Pharmacology, Pharmacovigilance, Policy Compliance, Procedure Adherence, Product Development, Product Launch Planning

Preferred Skills:

Current Employees apply

Current Contingent Workers apply

Employee Status:

Regular

Relocation:

No relocation

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:

09/9/2026

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

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

Merck & Co, Inc Careers

Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

Work You’ll Do

At Merck & Co, Inc, we are committed to improving global health through groundbreaking research and innovative healthcare solutions. Our team is at the forefront of developing new therapies and vaccines that significantly impact public health worldwide. By joining us, you will collaborate with some of the brightest minds in the industry, using your skills to contribute to projects that save and improve lives around the globe.

Explore Career Paths

Whether you're seeking an internship, a graduate opportunity, or a professional position, Merck & Co, Inc offers a range of career paths in environments that promote rapid professional growth and development. Explore job opportunities in research, digital transformation, manufacturing, and more, all while benefiting from a culture that supports diversity and inclusion.

Innovate and Lead

Merck & Co, Inc is an ideal environment for those who lead with curiosity and the drive to innovate. Our leadership is committed to fostering a culture where inventive thinking and collaboration are encouraged, making it a perfect place for professionals who seek to make an impact through their work.

Develop Your Skills

With Merck & Co, Inc, you are not just getting a job; you're gaining access to unparalleled career development opportunities. Enhance your skills through diverse training programs, workshops, and continuous learning courses designed to help you grow at every stage of your career.

Benefits and Culture

We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

Join Our Team

Ready to advance your career at Merck & Co, Inc? Search open positions that match your skills and interests. We are continuously hiring and looking for passionate, creative, and solution-driven team players. Prepare your resume, sharpen your interview skills, and become part of a company that's dedicated to making a difference.

Stay Connected

Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Engage with us through our careers blog and by participating in networking events and employment fairs. Subscribe to receive personalized job alerts and the latest news tailored to your preferences. Discover the exciting and rewarding opportunities that await at Merck & Co, Inc. Join us in our mission to improve health and wellness around the world.
Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ
MRK
* Ladders Estimates

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