Abbott Senior Software Design Assurance 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 Senior SW Design Assurance Engineer. This position is 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. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Impact this role will have on Abbott:
Oversee and manage the operational aspects of ongoing SW projects activities
Compliance with SW development and validation SOP/WIs and participate in process improvement initiatives
Develop mechanisms for monitoring project progress and for intervention and problem solving with software teams
Design verification and validation test planning and execution
Design verification and validation test protocols and reports
Design input output trace matrix
Quality Planning, including internal product development, OEM-based, Clinical Product Development (CPDP), and design change projects
Provides project management assurance that software products meet customer requirements. Monitors and analyzes quality trends in software to assure that quality problems are resolved, achieving cost and quality improvements and customer satisfaction.
Fosters communication and cooperation between software quality, software development, information technology, software support teams and the user community.
Promote risk based validation process by ensuring the defined software validation policies and procedures are appropriate and followed for each system being validated.
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Lead Risk Management activities from product Concept through Commercialization
Design specification reviews
Design change plan/reports
Ability to work independently with minimal/no supervision
Ability to coach/mentor junior and/or entry-level Engineering personnel/staff
Maintain high standards for content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating & resolving gaps
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Support all Divisional initiatives as identified by divisional management and in support of quality management systems (QMS), environmental management systems (EMS), and other regulatory requirements
Perform other duties and responsibilities as assigned by functional management based on the current project/business objectives including 10% travel, including international travel and regular predictable attendance
Your experience(s), education and knowledge will further expand Abbott’s marketplace success:
Bachelor level degree in an Engineering Discipline
10+ years’ experience
Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
Working understanding of FDA, GMP, and ISO 13485
Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
Ability to leverage and/or engage others to accomplish projects.
Multitasks, prioritizes and meets deadlines in timely manner.
Ability to work both within a team, and independently, in a fast-paced, changing environment.
Project management experience
Your preferred qualifications and education:
Prior medical device experience preferred
Degree in Mechanical, Biomedical, or Electrical Engineering
Team leadership experience
Experience working in a broader enterprise/cross-division business unit model
Working understanding of the following standards 60601, 14971, &/or 62304
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