Principal Scientist, Human Factors

About this role

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.

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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 Preferred Skills:

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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. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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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 pa

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