Device Development Engineer (Project Leadership) - Regeneron Pharmaceuticals

Regeneron is currently looking for a Device Development Engineer within the Combination Product Development Project Leadership Team. In this position, you will be responsible for leading innovative combination product device development projects through collaboration with diverse cross functional teams.
A typical day for a Device Development/Sr. Device Development Project Leader might include:

• Developing, tracking, and optimizing overall integrated project schedule and budget across all workstreams and functions throughout the entire lifecycle of the device development.
• Being the responsible device program representative that consults cross functional CMC (Chemistry Manufacturing Controls) and Global Development teams on respective development programs
• When scope change is required (by the Steering Committee or other drivers), responsible for finalizing vital technical and logistical elements supporting the decision making by site and global governance committees – with particular focus on technical, regulatory, and timeline impact
• Leading a cross functional device development engineering team through relevant design control milestones, technical challenges, and program strategy goals
• Leading kick offs, workshops and regular meetings with Partners and Global Development teams, to drive effective project execution.
• Representing the combination product group at appropriate industry meetings, conferences, and forums.
• Manage, coach, and/or mentor junior staff through the nuances of leading a development project (if applicable).
• Collaborating optimally with functional areas, support functions, and alliance partner functions (if applicable) to integrate device development milestones and facilitate project delivery on time

This Role Might Be For You If You

• Have strong communication and interpersonal skills with the ability to influence, collaborate and deliver solutions in highly sophisticated, matrix environment.
• Have experience with the practical application of Design Control concepts within FDA regulated industry including 21CFR820.30, ISO 13485 and/or ISO 14971.
• Can learn on the fly and are known to drive for results within your team
• Have a strong sense of urgency, including personal dedication and ownership over work. You have a consistent track record to hold others accountable for delivery.
• Handle ambiguity well and can adapt quickly and motivate change based on new information.
• Have previous experience leading technical teams through complicated project and accurately anticipate future trends and implications
• Have knowledge in statistical principals or Six Sigma concepts.

To be considered for the Device Development Engineering role you must have a Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Electrical Engineering or a similar field and 2+ years of relevant experience.

• Sr. Device Development Engineer: B.S in Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Electrical Engineering or a similar field and 5+ years of relevant experience.
• Device Development Engineer: Bachelor of Science in the fields of Biomedical Engineering, Mechanical Engineering, Chemical Engineering, Electrical Engineering or a similar field and 2+ years of relevant experience.

Prior experience in the medical device or biotech industry and working knowledge of applicable regulations is strongly preferred. PMP certification preferred but not required. Level is determined based on qualifications relevant to the role.
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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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$71,100.00 - $135,800.00