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 113,000 colleagues serve people in more than 160 countries.
Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.
WHAT YOU’LL DO
A Staff (Principal) Design Assurance Engineer provides ownership of the Design Control deliverables required to support both new product development projects and design change projects
Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of
Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities for Complex Medical-Electrical Systems
Lead Risk Management activities from product Concept through Commercialization
Support design test and inspection method development, and lead method validation activities
Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
Support and ensure internal & external audit responses and on-time product re-certifications
Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
Develop and lead other team members
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
Performs other related duties and responsibilities, on occasion, as assigned
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelor level degree in Engineering or Technical Field; advanced degree preferred
Minimum of 8 years of Medical device engineering experience, with Integrating Systems or 10 years in a related Industry with relevant Software / System Integration experience.
Detailed knowledge of FDA, GMP, and ISO 13485, 14971
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
Prior medical device experience preferred
ASQ CQE certification preferred
Design for Six Sigma and Critical to Quality training and experience preferred
Experience working in a broader enterprise/cross-division business unit model preferred
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, proactive manner
Strong organizational and follow-up skills, as well as attention to detail
Ability to travel approximately 10%, including internationally
Ability to maintain regular and predictable attendance
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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