Abbott Senior Design Quality Engineer, Hardware in Irving, Texas
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 109,000 colleagues serve people in more than 160 countries.
ABOUT ABBOTT DIAGNOSTICS:
The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.
Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.
Our location in Irving, TX, currently has an opportunity for Senior Design Quality Engineer, Hardware
WHAT YOU’LL DO
Primary function is to review and participate in all aspects of product design control for On-Market and In-Development activity. It is expected to have a firm understanding of the design input, risk management, design verification, design validation and design output/transfer processes & tools as applied to hardware product development. Effective navigation & facilitation of these processes and procedures is paramount to ensuring product teams deliver safe and effective products.
Responsible for implementing and maintaining the effectiveness of the quality system.
Design/Change Control - Hardware responsibilities include participating in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity.
Risk Management – Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA’s, etc.
Design Verification/Validation – Understands and applies basic Design Verification/Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records.
Complaint/Defect Evaluation - Investigates complex complaints and/or defects with management oversight. Provides compliant solutions to a variety of complex problems. Ensures compliant documentation related to area of responsibility.
Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.
Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
Quality Engineering – Participates on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.
Ability to work effectively within a team in a dynamic & fast paced environment.
Ability to work on numerous projects in parallel. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multi-tasks, prioritizes and meets deadlines in timely manner. Anticipates the impact and risk of decisions and actions at both the project and organizational level.
Comprehends the implications & consequences of how proposed changes and project demands will affect both internal & external customers.
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 maintain regular and predictable attendance.
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelor's degree in Engineering or Technical Field or relevant combination of education & experience.
Minimum 5 years’ experience.
Engineering experience and demonstrated use of Quality tools/methodologies.
Detailed knowledge of FDA, GMP, ISO 13485, and ISO 14971.
Solid communication and interpersonal skills.
Strong 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.
Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
B.S. in Mechanical Engineering; Electrical Engineering; Biomedical Engineering; Life Science or closely related discipline
MS is preferred
5+ years’ experience covering the entire design control process in a team-oriented environment.
Prefer tool experience with Serena Business Manager, Siemens Teamcenter Product Data Management & IBM DOORS. Knowledgeable of FDA 21 CFR 820.30, Quality System Regulations (QSR), Medical Device Directive, ISO 13485/14971 guidelines and FDA 21 CFR Part 11.
Project experience in hardware testing practices, methodologies and techniques, particularly in testing medical devices is a plus.
Prior medical device experience preferred.
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 (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 , 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
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