Abbott Sr. R&D Production Development Tools Specialist in Abbott Park, 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.
Under general direction, has duties of instructing and checking the work of other design engineers.
Responsible for designing new products and processes and improving and maintaining existing products.
Manage Design History Files in APLM, provide users guidance on design control tools, develop training materials and supervise a small team (<5) of individual contributors. Act as a liaison between tool SMEs and R&D engineers/scientist to ensure users’ needs are clearly understood and the tool is used as intended. Comprehend Operating Procedure or Process document and convert into a tool requirement that is compliant with the document. Support document control in US and EU, during audits by performing queries or developing reports.
May conduct design analysis on components and/or assemblies to assist in the development process by ensuring designs are cost efficient, manufacturable, and reliable.
Communicates with the other engineering personnel to coordinate the interrelated design and assure project completion.
May act as internal consultant providing technical guidance on most complex projects.
This is a non-supervisory position.
Assist the development teams in ADD and AMD through the creation, routing and updates of Design History Files in APLM. Manage a small team of full-time individual contributors and contract workers. The core job responsibilities are:
Management of the governing procedures, training materials and point of use training materials (written and video) for the APLM tool.
Serve as the subject matter expert and training point of contact regarding APLM applications. This position also includes being the Global Process Owner for Design History File and management of all related operating procedures.
Support of all division audit activities related to DHF design documents and management of APLM access to the tool.
Responsible for using customer metrics/questions and issues identified through monthly surveillance to devise new materials.
Proactively identifying changes in APLM that will improve the customer experience and influence peers and upper management to support the successful implementation of changes.
Responsible for execution of informal and validation testing for APLM as determined by the APLM SMEs.
Management of the Lake County DHF Storage location and the retention of these design documents.
Associates Degree with 7+ years of experience.
5+ years’ experience in an FDA Regulated Industry in a Technical or Quality area.
3+ years’ experience in supervising personnel
2+ years data management experience in Assay functional area (preferred)
Excellent communication skills to be able to communicate with all levels of employee and ability to work with global teams.
Good written communication skills to be able to write procedures, training and mass email communications.
Work with minimal supervision or guidance.
BS or equivalent in Computer Science or other Technical Science area.
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