Abbott Senior Design Assurance Quality Engineer in St. Paul, Minnesota
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 103,000 colleagues serve people in more than 160 countries.
We are seeking an experienced, high caliber Sr. Electrical Design Assurance Quality Engineer. The Electrical Development Quality team is involved in product development, test method validation, design verification and validation (including hands-on test execution), and sustaining design support.
Impact this role will have on Abbott:
• Lead on-time completion of Design Control deliverables
• Drives design quality, reliability, and compliance to standards and regulations
• Brings electrical and hardware expertise to the product development process
• Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
• Works closely with program teams to ensure timely and accurate completion of Quality deliverables
• Lead Risk Management activities from product Concept through Commercialization
• Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
• Work closely with design test and inspection method development, and lead test method validation activities
• Incorporates post-market data into future product development
• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Responsible for ensuring proper processes and procedures are used, and drives both process and procedural improvements to maintain compliance and increase efficiency
• Exercises judgment in planning and organizing work; monitors performance and reports status.
• Support and ensure internal & external audit responses
• Support and ensure on time product re-certifications
• Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
• Support manufacturing process development & qualification for new product commercialization and product changes
• Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
• Builds a strong collaborative partnership with Research & Development to ensure cross-functional customer needs are met without creating barriers to development cost, time and scope
• Complete Document Change Request Reviews in a timely and objective manner
• Develop and lead other team members.
• Perform other duties and responsibilities as assigned by management.
• 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.
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
• Bachelor level degree in Electrical or Electronics Engineering, System Engineering or equivalent; advanced degree preferred.
• Minimum 5 years of experience in a degree-related field
• Experience with analog/digital circuit design and analysis, plus knowledge of electronic instruments
• Experience with product development (in a Development or Quality role), test method development and validation, test execution, failure analysis and risk management
• Experience with quality systems and standards compliance
• Excellent verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation 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 personal computing skills, including report writing, and familiarity with common MS Office applications
• Ability to work in a highly matrixed and geographically diverse business environment and able to follow direction
• 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.
• 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.
• Ability to maintain regular and predictable attendance.
Your preferred qualifications and education:
• Advanced degree in Electrical, Electronics or Systems Engineering
• Experience in the implantable medical device field
• Experience with EMI/EMC, Coexistence, and/or MR environment exposure on active implantable medical devices (simulation and testing)
• Familiarity with FDA/ ISO and IEC standards and regulations
• Prior design and development experience in the related field
• Statistical method and Critical to Quality training and experience
• Root cause analysis and Finite Elemement Analysis experience
• ASQ CQE or other professional certifications
• Experience working in a broader enterprise/cross-division business unit model
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 firstname.lastname@example.org