Regeneron Pharmaceuticals, Inc

Director Human Factors & Sustaining Engineering

Regeneron Pharmaceuticals, Inc • $147K — $286K *
Rensselaer, NY 12144In-Person
Pharmaceuticals & Biotech
11 - 15 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BS/BA in Engineering, Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, Human-Computer Interaction preferred
  • 10+ years of experience for Associate Director or 12+ for Director in relevant fields
  • Previous people leadership experience in technical teams
  • Experience in medical device or biopharmaceutical combination products
  • Knowledge of design controls and product lifecycle management

Responsibilities

  • Recruit, mentor, and retain a high-performing team in human factors and sustaining engineering
  • Manage competing demands with tact and diplomacy
  • Build relationships across product design, engineering, and regulatory affairs
  • Serve as internal expert on human factors regulations/standards
  • Connect usability findings to design control documentation
  • Own design changes from concept through implementation
  • Drive customer complaint investigations and manage Risk Management Files
  • Prepare accurate technical documentation and present to executives

Benefits

  • Support for professional development and career pathways
  • Work in a collaborative, cross-functional environment
  • Opportunity to impact patient safety and product quality
  • Engage with challenging, high-stakes projects
  • Flexible working hours with a structured work model
Full Job Description

This is a unique, dual-scope leadership role. You will lead our Human Factors Engineering team driving usability strategy, study execution, and regulatory engagement for products in development while also overseeing our Sustaining Engineering function, which safeguards the quality, compliance, and performance of combination products already in the hands of patients. Combination product design control is the thread that ties both functions together, and a solid command of design inputs and outputs, verification and validation, design transfer, and change control is essential to succeeding in this role. If you want a role where design and lifecycle ownership meet, and where your team's work touches products from first usability study through years of commercial distribution, this is it.

When & where:

  • Location: East Greenbush, New York, United States
  • Work model: Monday-Friday, 8am-5:00pm
  • Travel percentage: 15% domestic & occasionally international

What you’ll do:

  • Recruit, direct, mentor, and retain a high-performing team of human factors and sustaining engineers supporting multiple projects across development and commercial lifecycle stages; build onboarding and career pathways that help engineers across both disciplines grow
  • Bring prior people-leadership experience across technical, cross-functional teams, with the ingenuity and composure to prioritize competing demands under ambiguity, tact, and diplomacy
  • Build strong working relationships and move seamlessly across product design, engineering, clinical development, marketing, quality, and regulatory affairs including on submission strategy, content, and agency responses for HF-related questions
  • Serve as internal expert on human factors and combination product regulations/standards (IEC 62366, AAMI HE75, ISO 14971, FDA HF guidance, 21 CFR Part 4, 21 CFR 820 design controls, ICH Q8-Q11); ensure usability engineering and design control processes meet and exceed regulatory expectations while delivering real patient value
  • Apply end-to-end understanding of design control (inputs/outputs, V&V, design transfer, change control) to connect usability findings and sustaining changes back to the Design History File, keeping documentation aligned as products move from development to commercial distribution
  • Own design changes from concept through implementation; conduct design change assessments and technical evaluations for supplier, component, and manufacturing changes, including global filings and contract manufacturing changes as commercial footprint expands
  • Drive and document customer complaint investigations (root cause, CAPA) and maintain/evolve Risk Management Files using post-market surveillance and manufacturing data, with hands-on DHF/RMF management experience
  • Write and edit clear, accurate technical documentation (protocols, risk files, investigation reports, regulatory responses) and hold the team to the same standard; present team work, risks, and priorities to executive management and regulatory authorities, advising on process improvements and emerging regulatory issues

This role requires:

  • BS/BA in Engineering, Human Factors Engineering, Biomedical Engineering , Cognitive Psychology, Human-Computer interaction or related field is preferred
    • Associate Director Human Factors: 10+ years of experience
    • Director Human Factors: 12+ years of experience
    • Level will be determined based on experience
  • Previous people leadership experience
  • Experience in medical device, biopharmaceutical combination products, or a similarly regulated environment
  • Prior experience with, or oversight of, sustaining engineering, design controls, or product lifecycle management for medical devices/combination products

Salary Range (annually)

$147,800.00 - $286,900.00

About Regeneron Pharmaceuticals, Inc

Regeneron Pharmaceuticals is a biopharmaceutical company that discovers, develops, and commercializes pharmaceutical products for the treatment of serious medical conditions. The Company has therapeutic candidates in clinical trials for the potential treatment of cancer, eye diseases, and inflammatory diseases, and has preclinical programs in other diseases and disorders. The company’s product portfolio includes EYLEA, an aflibercept injection; ARCALYST, a rilonacept Injection for subcutaneous use; ZALTRAP for metastatic colorectal cancer; trap fusion proteins; and fully human monoclonal antibodies. On March 26, 2012, it was announced that Sanofi and Regeneron are in development with a new cholesterol drug which will help reduce cholesterol up to 72%. Regeneron Pharmaceuticals was founded in 1988 and is currently headquartered in New York, USA.

Regeneron Pharmaceuticals, Inc Careers

Join the innovative team at Regeneron Pharmaceuticals, Inc, a leading biotechnology company renowned for its commitment to science-driven solutions. This is an unparalleled opportunity to advance your career with a company at the forefront of medical breakthroughs and clinical research.

Work You’ll Do

At Regeneron Pharmaceuticals, Inc, you will collaborate with some of the brightest minds in the industry, engaging in work that directly contributes to the health and well-being of populations globally. Our diverse team of professionals is dedicated to pioneering developments in biotechnology through continuous innovation and rigorous research.

Explore Job Opportunities and Growth

Regeneron offers a variety of job opportunities that encourage professional growth and personal achievement. Whether you're seeking an entry-level position or a more senior role, you will find a path that aligns with your career ambitions and skills. Our supportive culture emphasizes leadership development and diversity training, ensuring every team member can thrive.

Internship Programs

Kickstart your career with a Regeneron internship. Our programs provide invaluable industry experience, mentoring from seasoned professionals, and opportunities to develop skills that are crucial in the biotech field. Interns at Regeneron gain hands-on experience, contributing to projects that matter.

Benefits and Culture

Choosing to work at Regeneron Pharmaceuticals, Inc means choosing a career that comes with competitive benefits designed to support you both professionally and personally. We offer comprehensive health benefits, retirement plans, and wellness programs. Our inclusive culture fosters an environment where every employee can flourish, driven by collaboration and mutual respect.

Innovation and Leadership

Lead the way in biotechnological innovation with Regeneron. Our leadership is constantly looking towards the future, investing in cutting-edge technology and research that pave the way for medical advancements. At Regeneron, leadership and innovation go hand in hand, creating a dynamic where breakthroughs are common.

Networking and Professional Development

Enhance your professional network and skill set through Regeneron’s extensive networking opportunities and ongoing professional development programs. We believe in nurturing our talent with advanced training sessions and regular workshops that cover the latest trends and technologies in the biotech industry.

Join Our Team

Discover the impact you can make in a career at Regeneron Pharmaceuticals, Inc. Search for open positions that match your skills and interests. We are continuously hiring and looking for passionate, curious, and innovative team players.

Stay Connected

Keep up to date with the latest at Regeneron by following our careers blog. Gain insights from the experts and learn more about the exciting world of biotech at Regeneron Pharmaceuticals, Inc.

Prepare for Your Interview

Ready to join us? Prepare your resume and refine your interview skills to become part of a company that’s dedicated to changing lives. Personalize your job search and get tailored job alerts directly to your inbox, so you never miss an opportunity to be part of our team. At Regeneron Pharmaceuticals, Inc, your career is poised for tremendous growth and innovation. Explore the opportunities today and be part of a team that’s shaping the future of biotechnology.
Learn more about Regeneron Pharmaceuticals, Inc
Size
10,368 employees
Market Cap
$78.1 billion
Industry
Pharmaceuticals & Biotech
Net Income
$3.5 billion
Founded
1988
5 Year Trend
+27%
Revenue
$8.4 billion
NASDAQ
REGN
* Ladders Estimates

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