Abbott Senior Development 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 107,000 colleagues serve people in more than 160 countries
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.
We are seeking a Senior Development Quality Engineer to join our SH team in either our Saint Paul, MN or Plymouth, MN location. The individual in this position will assure new or modified products conform to requirements and establish compliance with the quality system. 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. This position will support new product development projects and lead completion of design control deliverables.
Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. 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.
WHAT YOU’LL DO
Primary Duties and Responsibilities:
Lead on-time completion of Design Control deliverables
Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects
Accountable for Design Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities
Lead Risk Management activities, including analyzing field data to support new product development, and supporting Failure Mode Effects Analysis
Support design test and inspection method development, and lead method validation activities
Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating and resolving gaps
Support manufacturing process development and qualification for new product commercialization and product changes
Support internal and 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
Support the development and review of biocompatibility and sterilization validations
Supports R&D product builds for bench testing, animal lab, and first in human activities.
Complete Document Change Request Reviews in a timely and objective manner
Participates in Corrective Action/Preventive Action (CAPA) process including the investigation of failures or deviations, as required. Develop and lead other team members.
Additional duties may be identified by functional management based on the current project/business objectives.
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
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelor’s degree within an Engineering field or related science-based discipline
5-8+ years of related work experience
Previous Quality engineering experience and demonstrated use of Quality tools/methodologies
Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization
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.
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.
Advanced degree in a technical field
Medical device experience, specifically with valves and /or implantable devices
Experience working in a broader enterprise/cross-division business unit model
Prior experience working with any or all of the following:
ISO 13485 Medical Devices – Quality Management System
21 CFR Part 820 FDA Quality System Regulations
ISO 14971 Medical Devices – Application of Risk Management
Good Manufacturing Practices And Good Documentation Practices
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 at http://www.abbottbenefits.com/pages/candidate.aspx
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 at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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