Abbott Principal Manufacturing Process Engineer in Lake Forest, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Develops and drives a comprehensive strategy to manage the performance, quality, and growth of a global, complex medical device product portfolio.
Responsible for managing the product production capacity to ensure delivery to long-range forecast and delivery to business growth targets. Including the strategic implementation of new technologies and design.
Develop and ownership of a data-driven process and models to monitor and proactively address performance and quality at external product suppliers and internal assembly equipment.
Strength in advanced data acquisition, monitoring, and analytics from complex, global systems.
Develops and applies advanced theories, methods and research techniques to the investigation and solution of complex technical problems.
Develops processes that lead to enhanced performance and quality; makes major impact decisions.
As a technical specialist, is assigned problems which require unique design/ research approaches. Devises new approaches to problems which vary from standard techniques and procedures.
Stay abreast of the technological advances in the engineering and other technical fields along with changes to the safety and performance standards.
Strategic Integrate customer needs, technical capability, and business drivers to propose and help drive product strategy.
Balance product quality, performance, time to market, and cost issues in order to meet ADD goals.
Provide the forum to facilitate communication, problem solving, and goal alignment between technical, operational, and commercial organizations.
Work with functional leadership to determine and ensure appropriate resource availability and assignments.
Work with functional leadership to anticipate and solve problems.
Follow an increasingly complex and evolving Design Control system throughout for product development activities.
The incumbent is accountable for maintaining high quality and productive work product in support of these projects.
Responsible for implementing and maintaining the effectiveness of the quality system.
B.S. Engineering or equivalent plus progressive technical experience and demonstrated competence. Knowledge of regulations and standards affecting IVDs and Biologics. A Masters or PhD Degree is preferred.
5+ years of related experience
Knowledge of design control, and risk management practices as well as a working knowledge of FDA Quality System Regulations and PMA / 510k filing requirements.
Must be familiar with the technologies employed in medical device systems such as numeric analysis and mechanical engineering.
Knowledgeable in the management and analysis of large data sets using Excel, MATLAB or similar data analysis tools.
Must have the ability to analyze product proposals and to manage the creation of top level conceptual architectures and context diagrams.
Written and verbal communication skills are vital along with good negotiating skills to allow the incumbent to direct multidisciplinary teams toward solutions.
Ability to multitask the numerous Systems activities related to new product development, on-market and change management to be able to lead based on expertise and pragmatism.
Strong communication skills with the ability both absorb and present complex information.
Must have the ability to work on many projects concurrently, where external events determine task switching.
Must be flexibility and open with a willingness to adopt or present the solutions of others.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org