Responsible for managing a Quality Group that supports development of mechanical circulatory support systems for patients with heart failure.  Products include mechanical pumping systems, electronic controllers, power sources, and other devices for temporary and long-term management of heart failure. 

WHAT YOU’LL DO 

Responsible for managing a Quality Group that supports development of life-saving and innovative systems for patients with heart failure.  Products include mechanical pumping systems, electronic controllers, power sources, monitoring systems and other devices for temporary and long-term management of heart failure.  The position:

• Plays a key role in establishing, planning and preparing design control deliverables for medical devices.  
• Manages employees who exercise significant latitude and independence including managers and engineers.  Performs management responsibilities including goal setting, monitoring and reviewing performance, conducting performance appraisals, recommending staffing levels and budgetary needs, and ensuring personnel development and training.
• Defines, leads, and prepares on-time completion of design control deliverables.  Ensures implementation of quality policies, processes, and procedures of the design control subsystem. 
• Leads and/or oversees risk management activities from product concept through commercialization. 
• Works closely with the research and development organization during the entire stage gate process to ensure product requirements meet customer expectations and potential product issues are identified and addressed in design.
• Communicates effectively on project status, success and risks that could impact customer satisfaction or project objectives.
• Strategizes and serves as a multi-disciplined thinker who develops proposals to address issues and resolve project risks. 
• Maintains development related documentation and establishes procedures that affect department and development processes. 
• Plans and initiates projects to improve process flows and identifies adequate control points.
• Serves as a key interface between Quality and R&D organizations.  Responsible for maintaining a strong collaborative partnership with cross-functional team members. Maintains positive and cooperative communications with all levels of employees, customers, contractors, and suppliers. 
• Support design verification and validation planning and execution, including active cross-functional root cause analysis investigation and resolution activities.  Support design transfer including process validation activities.
• Drive best practices for test method development and lead test method validation activities. 
• Ensures compliance with U.S. FDA regulations, EU and other country regulations, consensus standards, company policies and procedures. 
• Serves as a design control technical specialist for internal and external audits.  Ensures audit preparedness including availability of DHF records.
• Additional duties may be identified by functional management based on the current project/business objectives.  

EDUCATION AND EXPERIENCE YOU’LL BRING 

Required 

• Bachelor’s degree in Engineering or Sciences.
• 9 years of experience preferably in quality/technical area of implantable medical devices; Demonstrated leadership experience. 
• Demonstrated leadership experience. 
• Managed/Supervised technical personnel for at least 3 years.   
• Strong knowledge of regulations and standards affecting medical devices.

WHAT WE OFFER  

At Abbott, you can have a good job that can grow into a great career. We offer: 

·       A fast-paced work environment where your safety is our priority

·       Production areas that are clean, well-lit and temperature-controlled

·       Training and career development, with onboarding programs for new employees and tuition assistance  

·       Financial security through competitive compensation, incentives and retirement plans  

·       Health care and well-being programs including medical, dental, vision, wellness and occupational health programs 

·       Paid time off  

·       401(k) retirement savings with a generous company match 

·       The stability of a company with a record of strong financial performance and history of being actively involved in local communities 

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com  

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity. 

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