Principal Development Engineer I/II - R&D Combination Products Development & Drug Delivery

AbbVie - Irvine, CA

Full-time - Principal

Irvine, CA

Chemical Manufacturing

About the position

The Principal Development Engineer I/II role at AbbVie focuses on driving innovation in drug delivery devices, particularly in the areas of Eye Care, Neurotoxins, and Aesthetics products. This position is integral to the multidisciplinary device pipeline projects, requiring a blend of engineering expertise and biopharmaceutical knowledge to solve complex problems related to drug delivery mechanisms and user interactions. The role emphasizes collaboration, mentorship, and the promotion of an innovative culture within the team.

Responsibilities

• Function as a principal investigator and device technical lead, generating original technical ideas, research, and development strategies.
• Execute feasibility and engineering confidence tests to determine design viability and margin.
• Participate in Human Factors ethnographic research and User Needs development.
• Promote entrepreneurial thinking, and manage results with respect to quality, time, budget, and resources.
• Thoroughly document and communicate results through authorship of technical memos, reports and presentations.
• Author Records of Invention and documentation to build AbbVie's IP portfolio, and support Legal team in negotiating partnership agreements.
• Drive an internal culture of innovation, including application of Innovation Engineering formalisms, developing and curating a portfolio of problem statements across the portfolio, leading structured ideation sessions, and encouraging creativity.
• Lead and support device technology landscaping evaluations.
• Maintain visibility as a sought-out expert in her/his field, through regular attendance at internal and external symposia, presentations, and/or via publications.
• Collaborate with external companies/firms, maintaining and building strong relationships with key partners.
• Provide mentorship to junior team members.

Requirements

• BS, MS, or PhD in Mechanical Engineering or related discipline.
• Principal Engineer I minimally requires BS and 14 years, MS and 12 years, or PhD and 6 years of relevant experience.
• Principal Engineer II minimally requires BS and 16 years, MS and 14 years, or PhD and 8 years of relevant experience.
• Experience developing a range of medical devices, preferably in the drug delivery space.
• Familiarity with Design Controls (CFR 820.30 / ISO 13485) and Risk Management (ISO 14971), computational analysis (FEA, system modeling, etc) and descriptive statistics, and 3D CAD modeling.
• Excellent English language written and verbal communication.
• Strong interpersonal and influencing skills and ability to work effectively in a diverse team setting without direct authority.
• A strong sense of urgency and ability to work both independently and collaboratively in a highly dynamic and fast-paced environment.

Nice-to-haves

• Design for Six Sigma experience is desired.
• A proven track record of solving challenging problems, innovating and building and cultivating a culture of innovation.
• Demonstrated command of scientific principles and physiology/anatomy/biology relevant to localized drug delivery via the intradermal, intramuscular, and intraocular routes of administration.
• Comfort with hands-on problem solving and rapid prototyping.
• Prior people leadership experience and a desire to mentor.
• Facility with use of technology for data and information management.
• A keen eye for identifying project risks and proactively developing mitigation plans.

Benefits

• Health insurance coverage
• Dental insurance coverage
• 401k benefit for retirement savings plan
• Paid holidays
• Flexible scheduling
• Professional development opportunities