Abbott Manager Operations - Structural Heart in Menlo Park, California
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.
Primary Job Function
This position is responsible for the development and implementation of manufacturing activities to meet production schedules, quality standards, and cost objectives in a regulatory environment. The role will prioritize production schedules based on product introduction, equipment efficiency, and materials supply. Plans and administers procedures and budgets, both operational and capital. Selects and develops personnel to ensure the efficient operation of the production function. Identifies and executes continuous improvement opportunities. Will manufacture product for clinical trials, experimental trials and saleable product.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
- Responsible for the activities to manufacture product to design requirements, FDA guidelines and operating
Develop functional strategies and plans to realize the Operations Business strategy. Drives sustainable improvement with a relentless focus on productivity and cost. Champions operations excellence, including change management, business excellence and benchmarking.
Champion quality and compliance through effectively monitoring the performance of products and services. Leads quality system improvements that eliminate compliance risks and exceed external standards. Make decisions that fully comprehend and support expectations in quality and compliance.
Develop key performance indices, set goals and develop plans for continuous improvement in quality, cost, and employee performance.
Lead the production training team focused on hiring, onboarding and training of manufacturing personnel.
Develop a high-performance team.
Advise and assist the Director of Operations in general areas of manufacturing.
Participate in new product design and development reviews and design control activities effecting manufacturing.
Maintain a culture focused on employee safety.
Position Accountability / Scope
Position is accountable for production of commercial and development builds.
Bachelors Degree plus 10+ years experience, or an equivalent combination of education and work experience.
Minimum Experience / Training Required
Knowledge of regulations and standards of medical devices, including Class III devices, is preferred.
Manufacturing experience with companies engaged in the manufacture of high quality, complex, and regulated products.
Proven leadership skills, results oriented, highly collaborative, team player, and self-starter who can operate in a fast pace environment. Experience in state-of-the-art, multi-step, high complexity, process control manufacturing and process development. Experience with ISO 9001/CE Mark requirements. Manufacturing management experience in manufacturing planning, documented systems, GMP, and quality.
Preferred experience in lean manufacturing and 5S.
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 email@example.com