Device Engineer I/II/III

Who we are

REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.

As our Device Engineer, you will be part of a team responsible for the development of drug delivery systems for recombinant adeno-associated virus (AAV) gene therapy products. You will support a portfolio containing delivery technologies intended for localized delivery, including ocular and intrathecal routes of administration, and for systemic intravenous delivery.

In this role, you will contribute to device feasibility evaluations, design and development, risk management, and human factors engineering. You will work independently and as a part of cross-functional teams on assigned projects, prioritize projects to meet departmental and organizational goals, and communicate results in technical reports and presentations. 

What you'll be doing

• Contribute to device design and development, risk management, and human factors engineering activities according to relevant regulations and industry standards, including 21 CFR 820, ISO 13485, EU Medical Device Regulation, ISO 14971, and IEC 62366.
• Support medical device and combination product development on internal programs and activities with external device suppliers and development partners.
• Develop and qualify device test methods and author SOPs.
• Perform drug-device compatibility studies and device safety and functionality testing to support device feasibility studies, engineering assessments, and design verification.
• Author technical protocols and reports, including documents for project Design History Files.
• It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships, and using clear communication to meet shared objectives.
• This role requires travel up to 10% of the time.

We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:

• The ideal candidate will have a Bachelor’s or Master’s degree in a relevant engineering/scientific discipline.
• For Device Engineer I, the ideal candidate will have a Bachelor’s degree and up to 2 years of direct, relevant experience.
• For Device Engineer II, the ideal candidate will have a Bachelor’s degree with 2 to 5 years of direct, relevant experience or a Master’s degree and up to 2 years of direct, relevant experience.
• For Device Engineer III, the ideal candidate will have a Bachelor’s degree with 5 to 8 years, or a Master’s Degree with 2 to 5 years of direct, relevant experience.
• Able to independently plan and perform experiments that support scientific/engineering activities and project goals.
• Able to interpret data, draw conclusions, and recommend next steps.
• Able to effectively communicate information and results in the appropriate format (i.e., lab notebooks, presentations, reports, etc.).
• Familiarity with Design Controls, Risk Management, and Human Factors Engineering for medical devices and combination products is preferred.
• Ideally has an understanding of drug-device interactions.
• Must be able to work collaboratively and effectively as part of a team.