Manager, Human Factors

Regeneron Pharmaceuticals • Rensselaer, NY

8d • Onsite

About The Position

Regeneron is currently looking for a Manager- Human Factors to join our Process Sciences Drug Product Engineering department. This role will lead the human factors and usability department within Combination Product Development, which provides human factors expertise across the complete project portfolio from needs identification through sustaining engineering. The Human Factors group ensures that combination products and other products are developed through user-centered design. As a Manager- Human Factors, a typical day might include the following: Manages all Human Factors engineers and related personnel. Improves existing systems or leads the development of new systems to assure efficient and correct project outcomes. Works closely with other group managers to assure overall development program success. Creates new and manages existing relationships with vendors, partners, and key opinion leaders in industry. Analyzes device designs, instructions for use, labelling, and packaging. Provides suggestions for improvement to assure alignment to industry standards and regulatory expectations. Guides department interactions with key counterparts within the Regeneron organization, including combination products regulatory, regulatory labelling, quality assurance, and the product development team. Identifies opportunities for professional development among the human factors engineers and the broader combination product development group in order to elevate the knowledge and prowess of the team. Provides leadership to IOPS related to the integration, development, and promotion of human factors and usability engineering-related endeavors. Leads the recruitment and development of engineers for the human factors and usability engineering team. Assures work activities are conducted in a manner compliant with all applicable regulations and industry standards. Represents IOPS and the Combination Product Development group at appropriate industry meetings and forums. Willing and able to travel up to 25% annually. This role might be for you if you : Possesses strong technical writing and oral communication skills. Have experience preparing Human Factors information for 510(k), BLA, IDE, and PMA submissions. Have experience with IEC 62366, HE75, FDA Human Factors Guidance's, and/or human factors guidance's from other regulatory authorities. Have experience with submissions including human factors data outside the US, such as EMA, MHRA, PMDA, NMPA, etc. Have experience in and enjoy managing people, focusing on their development. Have experience with a wide variety of human factors skills, such as ethnography, contextual inquiry, heuristic analyses, and formative/validation usability studies.

Requirements

• BS in Engineering (Human Factors Engineering preferred) or Life Sciences
• 7+ years of relevant experience
• Previous experience with formative and validation human factors studies is required
• Previous people leadership/ supervisory experience is required
• Possesses strong technical writing and oral communication skills.
• Have experience preparing Human Factors information for 510(k), BLA, IDE, and PMA submissions.
• Have experience with IEC 62366, HE75, FDA Human Factors Guidance's, and/or human factors guidance's from other regulatory authorities.
• Have experience with submissions including human factors data outside the US, such as EMA, MHRA, PMDA, NMPA, etc.
• Have experience in and enjoy managing people, focusing on their development.
• Have experience with a wide variety of human factors skills, such as ethnography, contextual inquiry, heuristic analyses, and formative/validation usability studies.
• You must be willing and able to work Monday-Friday, 8am-4:30pm and travel occasionally.

Nice To Haves

• Experience in the medical device industry or in the medical device group of a pharmaceutical or biotech company is preferred.

Responsibilities

• Manages all Human Factors engineers and related personnel.
• Improves existing systems or leads the development of new systems to assure efficient and correct project outcomes.
• Works closely with other group managers to assure overall development program success.
• Creates new and manages existing relationships with vendors, partners, and key opinion leaders in industry.
• Analyzes device designs, instructions for use, labelling, and packaging.
• Provides suggestions for improvement to assure alignment to industry standards and regulatory expectations.
• Guides department interactions with key counterparts within the Regeneron organization, including combination products regulatory, regulatory labelling, quality assurance, and the product development team.
• Identifies opportunities for professional development among the human factors engineers and the broader combination product development group in order to elevate the knowledge and prowess of the team.
• Provides leadership to IOPS related to the integration, development, and promotion of human factors and usability engineering-related endeavors.
• Leads the recruitment and development of engineers for the human factors and usability engineering team.
• Assures work activities are conducted in a manner compliant with all applicable regulations and industry standards.
• Represents IOPS and the Combination Product Development group at appropriate industry meetings and forums.
• Willing and able to travel up to 25% annually.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees