Senior Device Development Engineer (Project Leadership)

Biopharma Careers; United States; On-site; USD 75,000 - 144,000; Full time

Job summary

Regeneron is seeking a Senior Device Development Engineer to lead end-to-end development of a device combination product and platform delivery system. You will guide multidisciplinary teams, define requirements, and ensure DHF compliance across FDA-regulated processes.

The role emphasizes project leadership, risk management, and collaboration with manufacturing, QA, and regulatory groups to support go-to-market strategies and lifecycle management.

Qualifications

• BS in Engineering with 5+ years of relevant experience.
• Experience in product/project management or leadership activities.
• Strong knowledge of FDA regulations (design controls) and DHF management.

Responsibilities

• Leads multidisciplinary engineering teams through the full design and development lifecycle of combination products.
• Defines product requirements and design inputs with stakeholders; ensures user needs are validated.
• Develops program plans, timelines, and budgets; communicates with internal and external teams.

Skills

Project management

Regulatory compliance

Cross-functional leadership

Design controls

Quality assurance

Education

BS in Engineering

Job description

Build our future together:

Regeneron is seeking a Senior Device Development Engineer to join our project lead team. The Sr. Device Development Engineer will drive the end-to-end development of a device combination product and/or platform delivery system, within a specific therapeutic area (Ophthalmic, Immunology/Inflammation, Cardiometabolic, etc.). They will provide comprehensive leadership in engineering product management, regulatory compliance (design controls), and multi-functional collaboration with internal and external partners, for the combination product device.

When & where:

• Location: East Greenbush, New York, United States
• Work model: Monday-Friday, 8am-4:30pm
• Travel percentage: 10% domestic & occasionally international

Discover your role:

• Leads multidisciplinary engineering teams (Human Factors, V&V, Manufacturing, Quality) through the full design and development lifecycle of combination products within the Regeneron pipeline
• Defines product requirements, technical specifications, and design inputs in collaboration with commercial, clinical, and engineering stakeholders; ensures all user needs are validated through design and development
• Understands design inputs/outputs across multiple delivery systems and their impact on end users
• Develops, manages, and communicates program plans, risks, timelines, and budgets to internal and external teams
• Possesses strong project management, interpersonal, analytical, and problem-solving skills
• Integrates device development with CMC and global development timelines; supports internal/external manufacturing teams on design and process information transfer
• Leads product testing and quality assurance processes; ensures a compliant Design History File (DHF) per 21 CFR Part 4 and 21 CFR 820.30
• Supports clinical/commercial regulatory activities related to device development (IND/IMPD, BLA submissions, Clinical Pharmacy Manuals)
• Deep understanding of FDA regulations (21 CFR Part 4, 820.30) and DHF management experience
• Supports strategic product launch and go-to-market planning with therapeutic area device leads

This role requires:

• BS in Engineering and 5+ years of relevant experience ; or equivalent combination of education & experience.
• Previous experience in product management/project management/ and/or project leadership related activities
• Level is determined based on qualifications relevant to the role

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. 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., https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

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.

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.

Salary Range (annually)

$75,300.00 - $143,900.00