• Mechanical Development Quality Engineer I Jobs in United States Of America

  • Abbott India Ltd
  • United States Of America, Usa

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 103,000 colleagues serve people in more than 160 countries

JOB DESCRIPTION Job Description Summary - Analyze quality standards for components, materials or services Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met

Job Description - We are seeking an experienced, high caliber Mechanical Development Quality Engineer to assure new or modified products conform to quality standards and establish compliance with the quality system 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 Employees act on their strong desire to make a difference, partner with others and put ideas into action Employees are engaged by a work culture that is team-oriented, fast paced and progressive

Impact this role will have on Abbott

Execute and support on-time completion of Design Control Deliverables
Support and ensures the proper prediction of, and the ultimate product performance of the electrical system
Evaluates product design to identify potential design issues and drive technical decisions
Able to troubleshoot and debug design issues and drive technical decisions
Support on-time execution of Quality Plans for internal development, OEM-based, and design change projects
Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
Support Risk Management activities from product Concept through Commercialization
Support design test and inspection method development, and lead method validation activities
Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
Support manufacturing process development & qualification for new product commercialization and product changes
Support internal & external audit responses
Support product re-certifications
Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements
Support objective component specification definitions, supplied component sampling plan development, and vendor qualifications
Complete Document Change Request Reviews in a timely and objective manner
Additional duties may be identified by functional management based on the current project/business objectives
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 US 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


Work with a variety of production and lab equipment, small hand tools, test equipment and precision measuring instrument Also uses standard office equipment such as telephone, fax/copier and a personal computer with standard office software

Working Conditions

Work environment varies from well lighted office/cubicle, low to moderate noise level, production environment, labs, to a variety of conditions caused by travel requirements such as customer offices, research labs, testing labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc

Physical Demands
Activities require a significant amount of sitting in front of a computer monitor, some standing and walking Significant use of hands and arms, plus finger dexterity to reach, point, write, type, operate a computer and other office equipment, lab equipment etc Perform tasks that regularly require good correctable vision and hand/eye coordination Activities also require significant use of voice and hearing for discussions with other employees May require some lifting or moving of lab and office equipment etc

Your experience(s), education and knowledge will further expand Abbotts marketplace success

Bachelor level degree in Mechanical Engineering, System Engineering, Industrial Engineering or similar; advanced degree preferred
0-2 years experience in a degree-related field
Solid fundamental understanding of mechanics and materials
Hands on experience with lab testing and debugging of mechanical designs using standard lab equipment
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
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 PERCENT , including internationally
Ability to maintain regular and predictable attendance

Your preferred qualifications and education

Understanding of implantable medical field
Prior design and development experience in the related field
Statistical method and Critical to Quality training and experience
Root cause analysis (CAPA) experience
Experience with Design for manufacturing, Design of Experiment, design simulation and/or modeling
Familiarity with FDA/ ISO standards and regulations
ASQ CQE or other professional certifications desirable

JOB FAMILYEngineering

DIVISIONCAHF Cardiac Arrhythmias & Heart Failure

LOCATIONUnited States > Sylmar 15900 Valley View Court

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 18th Mar 2020

Key Skills:

Company Profile:

Abbott India Ltdarfix

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