Senior Design Quality Engineer, Hardware
Company: Abbott Laboratories
Location: Irving
Posted on: June 10, 2021
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Job Description:
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. Main Responsibilities: 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. Accountability/Scope: 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. EDUCATION AND EXPERIENCE YOU'LL BRING Required 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. Preferred 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. 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 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.
Keywords: Abbott Laboratories, Irving , Senior Design Quality Engineer, Hardware, Other , Irving, Texas
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