Principal Engineer - Medical Device Design (Boston, Ma)

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The DDCS Innovation function plays a vital role in Lilly’s mission to bring pioneering technology for the delivery of healthcare by investigating novel technologies both internally and through external collaborations that can assist in fulfilling this mission. The Innovation team will consist of core technology-focused science and engineering fields along with key external innovation subject matter authorities. Together this group will own new investments in delivery and device technologies that span all therapeutic areas.
 

We are seeking an Sr. Principal/Principal Engineer in DDCS Drug Delivery and New Product Innovation to design novel drug delivery procedures, methodologies, and devices. This individual will be responsible for mechanical and electro-mechanical engineering across multiple drug delivery platforms starting from the earliest stages of research and development.  Responsibilities will include a combination of new product ideation, concept development, mechanical design (in Solidworks), prototyping, fabricating, laboratory work, and literature research. You will be working at the cutting edge of drug delivery, helping enable new-to-the-world therapies being developed across Lilly Research Labs. Projects may include the support and expansion of existing therapies as well as designing delivery solutions for first-in-human use.

Key Objectives/Deliverables:

• Play a key technical role in the design and development of innovative drug delivery solutions to enable current and future drug portfolio assets.
• Participate in ideation activities for new products, delivery methodologies, and new procedures – may include both benchtop and ex vivo tissue experimentation.
• Design and create device prototypes for use in laboratory testing, ex vivo testing, and in vivo testing.
• Design and fabrication of test setups – including test fixtures to support prototype testing and characterization of current devices via sensors and instrumentation.
• Collect, analyze, and present data from experiments to project team, including recommendations for next steps.
• Work with external vendors including CMO’s and CRO’s to create prototypes, early in vivo testing setups, and perform in vivo experimentation.

People:

• Network and collaborate across functional groups and departments within a large, multidisciplinary company.
• Mentor more junior engineers and interns/coops.
• Assist in perpetuating an environment of collaboration and innovation, along with an expectation for step change improvement.

Basic Qualifications:

• BS in engineering, preferably in mechanical or electro-mechanical engineering (MS preferred), with 5+ years of experience in Medical Device or combination product design and development
• Experience and comfort with the ambiguity of early-stage R&D and innovation.
• Experience in designing combination products and procedures, including parenteral, inhalation, transdermal, intrathecal, and other direct CNS drug delivery methodologies.

Additional Skills and Preferences:

• Expert use of CAD (SolidWorks), working knowledge scripting (Python, Matlab) for data acquisition, instrument control and data analysis. Knowledge of statistical analysis (JMP, R) and Good Documentation Practices in a regulated environment.
• Strong laboratory experimentation skills, including rapid prototyping, fluid handling, fabrication, sensors and instrumentation, and design of experiments.

• Knowledge of anatomy and physiology, particularly of the central nervous system is highly desirable.
• Works well in small, multidisciplinary teams and as an individual contributor.
• Strong mechanical and product design skills, preferably in drug delivery and/or surgical products

• Intellectual curiosity and a desire to constantly learn and grow to help solve complex problems.
• Experience with drug pumps, their design and testing.
• Experience and understanding of the Medical Device lifecycle, design control, and general quality and regulatory requirements of stand-alone and combination devices.
• Working knowledge of the drug development process, including the chemistry and manufacturing side of drug delivery systems preferred.
• Enjoys the challenge of unsolved problems and understands the possibility of multiple solutions.

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