1+ months
2018-05-112018-07-20

Program Management Process

Abbott
Los Angeles, CA

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.

Education and certifications:

 

Bachelor’s degree, preferably in science, technology, engineering

 

Requirements and Position Description:

 

Experience with procedures and systems used for product development, design controls, design history file and manufacturing device master record.

 

Experience with large EDM (electronic document management) and PLM (product life cycle) systems and document management via the systems.

 

Direct experience with or exposure to quality, manufacturing, and supply chain functions preferred

 

Experience or familiarity with medical device and/or pharmaceutical industry regulations and standards:

 

·         US FDA Quality System Regulations for medical device manufacturers

·         International regulations, such as European Medical Device Regulations (new version of MDR in 2017, replacing former Active Implanted Medical Device (AIMD) regulations)

·         Product development standards such as ISO 13485, 14971, 62304 etc.

·         Newer requirements such as Universal Device Identification and Global Trade Identification Numbers

·         Product technical standards

 

Quality systems management within a medical device organization preferred.

 

Support product development users with templates and suggested content for a wide range of plans and reports.

 

Make concrete the abstract deliverables required by SOP’s and WI’s by providing well-drafted prototype documents and assistance with specific documents where appropriate. Maintain program management’s historical design history files and related information such quality reports.

 

Ability to improve product development infrastructure requires a good understanding of the relationship between and among, formal regulations and standards, the quality system, the working practices by which individuals deliver their  products, and facilitates crafting SOP’s and WI’s that simplify and optimize work product delivery while maintaining compliance.

     

Understanding of databases and ability to contribute to and implement useful small to medium scale database systems, such as for design history files.

 

Conceptualize interfaces and data export from EDM or PLM system to local database, such as for DHF management

 

Personal skills:

 

Must be conservative without rigidity in respecting regulations, standards, and quality system requirements, yet broad minded and innovative in devising solutions to new situations facing procedural gridlock or program delay. Maintain the product development and release flow while preserving responsible compliance.

 

High accessible and responsive because the position exists to support and meet requests from across the organization related to the product development process.

 

Excellent writing skills to Standard Operating Procedures (SOP’s) and Work Instructions (WI’s).

 

Presentation skills and ability to train others

 

Self-starter, detail and deadline oriented

 

Excellent computer skills: TeamCenter, Windchill, PowerPoint, Word, Excel, Visio

·      

 
Job Family: Product Development
Division: CAHF Cardiac Arrhythmias & Heart Failure
Travel: Yes, 5 % of the Time
Medical Surveillance: No
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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Program Management Process

Abbott
Los Angeles, CA

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Abbott
Los Angeles, CA
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