Director Human Factors & Sustaining Engineering

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 148,000 - 287,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in East Greenbush, NY invites a Director of Human Factors to lead HF Engineering and Sustaining Engineering for combination products, shaping usability strategy from development to commercial distribution.

You will recruit and mentor a high-performing team, engage with regulatory bodies, and ensure compliance with IEC 62366, FDA HF guidance, and design controls while driving risk management and post-market surveillance.

Qualifications

• BS/BA in Engineering, Human Factors Engineering, Biomedical Engineering, Cognitive Psychology, or related field preferred.
• Associate Director Human Factors: 10+ years of experience.
• Director Human Factors: 12+ years of experience.
• Previous people leadership experience.
• Experience in medical device, biopharmaceutical combination products, or similarly regulated environment.
• Prior experience with sustaining engineering, design controls, or product lifecycle management for medical devices/combination products.

Responsibilities

• Lead and mentor a high-performing team of human factors and sustaining engineers across development and commercial lifecycle stages.
• Demonstrate people leadership across technical, cross-functional teams under ambiguity with tact and diplomacy.
• Collaborate with product design, engineering, clinical development, marketing, quality, and regulatory affairs; support submission strategy and agency responses for HF 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).
• Ensure usability engineering and design control processes meet regulatory expectations while creating patient value.
• Oversee design changes from concept through implementation; perform design change assessments for supplier and manufacturing changes.
• Drive and document customer complaint investigations (root cause, CAPA) and maintain Risk Management Files.
• Write and edit protocols, risk files, investigation reports, regulatory responses; present risks and priorities to executives and regulators.

Skills

People leadership

Regulatory engagement

Human factors engineering

Design controls

Risk management

Education

BS/BA in Engineering

Human Factors Engineering

Biomedical Engineering

Cognitive Psychology

Human-Computer interaction

Job description

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Our Combination Product Development team ensures that every device patients and providers rely on from prefilled syringes to autoinjectors is safe, intuitive, and built to last. We're looking for a Director of Human Factors to shape how patients and caregivers interact with our devices, and keep our commercial products performing reliably long after launch. 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

Does this sound like you?

We are committed to building a workplace with an inclusive culture.

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Benefits and Compensation

• Salary Range (annually) $147,800.00 - $286,900.00
• Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.
• For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together.

For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.