Device Development Engineer

Regeneron Pharmaceuticals • Rensselaer, IN

1d • Onsite

About The Position

Regeneron is currently looking for a Device Development Engineer to join our technical lead team within Combination Product Development. This position includes lab and non-lab work. In this position, you will execute technical activities for combination products projects following design controls. A typical day for a Device Development Engineer might include: Review of applicable regulatory guidance and standards to ensure appropriate regulatory compliance. Establishing Design Inputs and associated technical translation rationales derived from user needs and regulatory requirements Conducting design verification and characterization/feasibility activities, including writing technical protocols and reports, establishing statistically appropriate acceptance criteria and sampling plans, coordinating sample builds and test execution. Drafting Design Outputs including drawings, specification documents, bills of materials etc. Identify key performance requirements and associated essential Design Outputs. Establishing recommended Control strategy (incoming, in-process, release and stability) for combination product. Providing technical oversight on Medical Device custom component manufacturing during development. Supporting review and/or preparation of technical documentation for regulatory submissions. Working closely with multi-functional teams to assure project success. Ensures that products being developed both internally and externally are technically robust through engineering analysis, ensuring that products perform sufficiently and reliably. Ensuring work activities are conducted in a manner aligned with all applicable regulations and industry standards. Maintaining a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments. Representing IOPS (Industrial Operations Product and Supply) and the devices group at appropriate industry meetings and forums.

Requirements

• Have experience with the practical application of Design Control concepts within FDA regulated industry including 21CFR820.30 and ISO 13485.
• Enjoy critical thinking, problem-solving, and implementing strategic improvements.
• Are eager to apply expertise in diagnosing inefficiencies, resolving root causes, and recommending solutions to challenges.
• Are able to establish and cultivate highly effective partnerships to support and advance project goals and objectives.
• Are willing to travel up to 10% annually.
• To be considered for the Device Development Engineer you must be willing and able to work Monday-Friday, 8am-4:30pm.
• You must have a B.S in Engineering; biomedical engineering, mechanical engineering is preferred.
• Associate Device Development Engineer:0-2+ years
• Device Development Engineer: 2+ years
• Sr. Device Development Engineer: 5+ years
• Or equivalent combination of education and experience
• Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820 / ISO 13485) is required.

Nice To Haves

• Experience in drug delivery space is preferred.

Responsibilities

• Review of applicable regulatory guidance and standards to ensure appropriate regulatory compliance.
• Establishing Design Inputs and associated technical translation rationales derived from user needs and regulatory requirements
• Conducting design verification and characterization/feasibility activities, including writing technical protocols and reports, establishing statistically appropriate acceptance criteria and sampling plans, coordinating sample builds and test execution.
• Drafting Design Outputs including drawings, specification documents, bills of materials etc.
• Identify key performance requirements and associated essential Design Outputs.
• Establishing recommended Control strategy (incoming, in-process, release and stability) for combination product.
• Providing technical oversight on Medical Device custom component manufacturing during development.
• Supporting review and/or preparation of technical documentation for regulatory submissions.
• Working closely with multi-functional teams to assure project success.
• Ensures that products being developed both internally and externally are technically robust through engineering analysis, ensuring that products perform sufficiently and reliably.
• Ensuring work activities are conducted in a manner aligned with all applicable regulations and industry standards.
• Maintaining a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments.
• Representing IOPS (Industrial Operations Product and Supply) and the devices group at appropriate industry meetings and forums.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level