Regeneron is seeking a Principal/Staff Device Development Engineer to join our project leadership team. They will drive the end-to-end development of device combination products and/or platform delivery systems, within a specific therapeutic area (Ophthalmic, Hematology, Cardio-metabolic, 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 developments in the designated therapeutic area.
A typical day for a Principal/Staff Device Development Engineer might include:
- Leads multidisciplinary engineering project teams (Human Factors, V&V Engineering, Manufacturing Engineer, Quality Engineering) through the complete device design and development lifecycle of a combination product development within the Regeneron Pipeline.
- Defines detailed product requirements and specifications with commercial, clinical, and other development/strategy stakeholders.
- Responsible for all user needs and requirements to be validated through design and development.
- Ensures comprehensive Design History File (DHF) is developed and ensures to meet regulatory and quality requirements (21CFR Part 3 and 21 CFR 820.30).
- Supports and aligns all clinical and commercial regulatory activities related to device development.
- Defines technical specifications and design requirements in collaboration with engineering teams (manufacturing, verification, packaging etc.)
- Develops, manages, and communicates development program plans, risks, timelines, and budgets.
- Leads all aspects of product testing and quality assurance processes for the device development.
- Drives product launch and go-to-market plans with CMC PM (Chemistry, Manufacturing & Controls Program Management) and other collaborators and project management teams.
- Understands crucial design inputs and outputs of different types of delivery systems (different delivery sites) and how it can impact end users.
- Seeks out continuous improvements and collaborative opportunities to improve device development processes and collaborator relationships.
- Leads post-launch life cycle management initiatives and product improvements.
- Represents end-user and device/product needs within the organization.
- May have people leadership/mentoring responsibilities.
This role might be for you if you:
- Can successfully manage sophisticated, multi-disciplinary development projects.
- Have a thorough understanding of relevant FDA regulations, particularly 21 CFR Part 3 and 21 CFR 820.30.
- Understand design history file management (21CFR 820.30).
- Possess project management and interpersonal skills and strong analytical and problem-solving capabilities.
- Can work optimally across multiple functional teams.
- Have experience with regulatory submissions and clinical protocol development.
- Can balance business objectives with technical constraints.
- Enjoy working in a fast-paced, multifaceted research and development environment.
- Are willing and able to travel for partner meetings, audits, and project coordination activities.
To be considered for the Principal/Staff Device Development Engineer you must have a B.S in Engineering. For various levels you must have the following:
- Principal Device Development Engineer: 8+ years of relevant experience
- Staff Device Development Engineer: 10+ years of relevant experience
Previous experience in product management/project management/ and/or project leadership related activities is preferred. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$101,800.00 - $194,500.00
What We Do
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
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