Sr. Manager Human Factors Engineering

Location
Rensselaer, NY, United States
Posted
Sep 25, 2020
Ref
19121BR
Required Education
Bachelors Degree
Position Type
Full time

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

  • Recruit, develop, and retain high-performing human factors engineers who act as essential team members for all Combination Product Development project activities
  • Organize and direct the work of the human factors engineering staff and outside consultants to effectively and efficiently support product development efforts
  • Develop collaborative working relationships with other functions that are focused on product development, such as product design and engineering, clinical development, and product marketing
  • Collaborate closely with internal regulatory functions, including labelling, strategy, and sciences, to develop strategies for product submissions, create submission content, and respond to questions from regulatory agencies
  • Act as an internal expert regarding regulations and best practices for medical device human factors, e.g., IEC 62366, AAMI HE75, ISO 14971, and the latest FDA guidance on applying human factors engineering
  • Ensure the company's usability engineering processes and methodologies meet and exceed the latest expectations of regulatory agencies and provide clear value to people living with serious disease; advise management regarding potential improvements to
    internal processes and regulatory issues related to human factors engineering.
  • Implement robust onboarding and career development pathways for staff that empower individuals to perform at their highest capacity


Education and Experience:

  • BS, MS, or PhD degree in an engineering discipline (industrial engineering, human factors engineering, biomedical engineer, etc.), another relevant discipline (cognitive psychology, human-computer interaction, etc.), or a related field.
  • At least 7 years of experience human factors/usability engineering experience in a product development organization, with a regulatory authority, or in another relevant function is required
  • At least 3 years of experience as a functional manager is required
  • Relevant human factors/usability engineering experience in medical device, biopharmaceutical combination products, or similar regulated industry is required
  • Experience preparing Human Factors information for 510(k), BLA, IDE, and PMA submissions is preferred.

 


Education and Experience:
• BS, MS, or PhD degree in an engineering discipline (industrial engineering, human factors engineering, biomedical engineer, etc.), another relevant discipline (cognitive psychology, human-computer interaction, etc.), or a related field.
• At least 12 years of experience human factors/usability engineering experience in a product development organization, with a regulatory authority, or in another relevant function is required
• At least 6 years of experience as a functional manager is required
• Relevant human factors/usability engineering experience in medical device, biopharmaceutical combination products, or similar regulated industry is required

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.