AbbVie-posted 2 months ago
Senior
Branchburg, NJ
Chemical Manufacturing

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.

  • 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.
  • Participates in ethnographic studies to support the development of User Needs, including identification of user groups, definition of surgical techniques and user-product interface.
  • 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.
  • Partners closely with cross-functional partners to understand internal expectations and requirements for development and makes recommendations for shifts in R&D strategy.
  • Supports project teams through creation of design & development deliverables to facilitate transfer of knowledge and ensure successful designs.
  • Facilitates 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.
  • Maintains ongoing connection with project teams to uncover opportunities for continuous improvement.
  • 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; ability to execute under minimal supervision.
  • Identifies, understands and proactively mitigates technical/product risk.
  • Ability to communicate highly technical information in a clear and easy-to-understand way (both verbally and in writing).
  • Demonstrated strong business acumen.
  • Experience in identifying and executing continuous improvement initiatives.
  • Team leadership experience.
  • Applied experience with statistical analysis; experience using Minitab preferred.
  • Demonstrated understanding of advanced engineering principles and practices.
  • Design Control knowledge and thorough understanding of medical device standards and regulations.
  • Demonstrated understanding of existing development methodologies.
  • Ability to distill complex experiment design into manageable studies.
  • Product development experience.
  • Experience using Computer-Aided Design (CAD) programs; Solidworks preferred.
  • Proficiency in Microsoft Office Suite including Word, Excel, PowerPoint, Visio, Project and Outlook.
  • Experience developing products within a business stage gate process.
  • Paid time off (vacation, holidays, sick)
  • Medical/dental/vision insurance
  • 401(k) to eligible employees
  • Short-term incentive programs
  • Long-term incentive programs
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