Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries
Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.
WHAT YOU’LL DO
- Develop and conduct training of company personnel for the divisional software development and validation program.
- Work with Design and Manufacturing Engineering in the completion of system/software requirements and other verification and validation processes.
- Create and execute or direct software validation protocols traceable to system/software requirements.
- Implement solutions for controlling code and administer Code Control and Software Event/Defect Tracking software systems.
- Assure new or modified products conform to quality standards and establishes compliance with the quality system.
- Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs.
- Be accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
- Support design test and inspection method development, and lead method validation activities
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
EDUCATION AND EXPERIENCE YOU’LL BRING
Engineering or Technical Field or an equivalent combination of education and work experience
Minimum 5 years
Previous Quality engineering experience and demonstrated use of Quality tools/methodologies. Detailed knowledge of FDA, GMP, and ISO 13485
Solid communication and interpersonal skills. Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner. Advanced computer skills, including statistical/data analysis and report writing skills.
Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel approximately 10%, including internationally.
- Masters degree
- Prior medical device experience preferred
- ASQ CSQE certification desired
- Experience working in a broader enterprise/cross-division business unit model preferred. Design for Six Sigma and Critical to Quality training and experience
- Software development life cycle for medical devices – ISO 62304
- Agile Software Development Lifecycle model
- Risk Management for Medical Devices – ISO 14971
- Design Controls specifically for complex software electomechanical devices
- Experience with machine learning
- Usability and human factors engineering
- JIRA and / JAMA suite of requirement management and software change tracking systems
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.