Sr. Product Development Engineer

Company Description

Abb Vie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Develops and implements tools, best practices and strategies to enable robust and efficient design and development of medical devices and combination products, with a heightened focus on early-stage development.

• Under general direction, the Senior Engineer will identify and prioritize various aspects of development to optimize based on the needs of the organization.
• Once identified as a priority, the Senior Engineer will conduct research to benchmark best practices where possible.
• The Senior Engineer will then lead efforts to develop, refine, gain alignment and implement best practices, strategies and associated tools, collaborating cross-functionally as necessary.

• Building Development Excellence:
  Identifies best practices, strategies and tools for product development to enable robust and efficient execution of design control and related aspects of product development.
• Develops and implements new methodologies and tools to facilitate good design & development practices, ensure timely decisions and mitigate project risk across various device types (e.g. combination products, tissue-based devices, injectable devices, capital equipment, 510(k) devices, PMA devices, etc.), including ideation and early research prior to initiation of design control.
• Initial focus is on various aspects of early-stage development (e.g. understanding relevant disease states, developing design inputs, executing design & process characterization studies, establishing design outputs, etc.).
• May participate in ethnographic studies to support the development of User Needs, including identification of user groups, definition of surgical techniques and user-product interface, and exploration of new applications.
• Provides technical expertise in establishing approach to defining product requirements / design inputs, designing product, developing appropriate test methods, analyzing data and resolving complex design problems associated with product performance.
• Partners closely with cross-functional partners to understand internal expectations and requirements for development and makes recommendations for shifts in R&D strategy to accommodate as necessary.
• Supports project teams through creation of design & development deliverables (e.g. control strategies, bridging strategies) to facilitate transfer of knowledge and ensure successful designs and design for manufacturability.
• Facilitate brainstorming/troubleshooting sessions to solve complex design challenges.

• Develops training materials and facilitates training sessions for project teams on newly created best practices and associated tools.
• Periodically engages with project teams post-training, as necessary, to assess adoption and effectiveness of tools and best practices.
• Maintain ongoing connection with project teams to uncover opportunities for continuous improvement. Engage with Design Control Solutions Team to ensure alignment of efforts.

• Bachelors Degree in engineering or related field with 8+ years Product Development experience, or Masters degree with 6+ years Product Development experience, or PhD with 4+ years Product Development experience
• Medical device experience or experience in a regulated environment
• Experience developing products within a business stage gate process (preferred)

• Demonstrated critical thinking and problem solving skills
• Ability to exercise judgment both within defined procedures and policies and balanced across technical and business needs
• Ability to manage diverse, simultaneous projects of varying complexities
• Self-motivated;…