Offers “Abbott”

Expires soon Abbott

Electrical Development Quality Engineer II

  • Sylmar, USA
  • Design / Civil engineering / Industrial engineering

Job description

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

JOB DESCRIPTION:

Description

We are seeking an experienced, high caliber Electrical 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.

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.

Impact this role will have on Abbott:

· Responsible for 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 electrical design issues and drive technical decisions

· Execute and support on-time completion of Design Control Deliverables

· Support Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities

· Creates and ensures on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects

· Prepares risk management files and report for product releases, and has responsibility for active participation in risk management activities from product conception through commercialization

· •Support design test and inspection method development, and execute method validation activities

· Supports DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

· Supports and ensures internal & external audit responses

· Support product re-certifications

· Supports and ensures 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

· 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 U.S. 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

Your experience(s), education and knowledge will further expand Abbott's marketplace success:

· Bachelor level degree in Electrical or Electronics Engineering, or equivalent; advanced degree preferred

· 2-5 years' experience in with electrical design, systems, or quality

· Solid fundamental understanding of analog and digital circuits

· Hands on experience with lab testing and debugging of electrical circuits using standard lab equipment

· Excellent verbal and written analytical/problem solving, communication, negotiation, interpersonal and presentation skills with ability to effectively communicate at multiple levels in the organization

· Advanced personal computing skills, including report writing, and familiarity with common MS Office applications

· Statistical data analysis skills

· Ability to work in a highly matrixed and geographically diverse business environment and able to follow direction

· 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

· Ability to maintain regular and predictable attendance

Your preferred qualifications and education:

· Experience in electrical circuit design and testing

· Working knowledge of Risk Management, ISO 14971, FTA and FMEA

· Experience in using a variety of electrical engineering tools for design simulation and/or modeling

· Experience/knowledge with EMI/EMC, Wireless Coexistence, and/or MR environment exposure on active implantable medical devices (simulation and testing)

· Familiarity with FDA/ ISO and IEC standards and regulations

· ASQ CQE certification

· Experience working in a broader enterprise/cross-division business unit model

Primary Location: USA-California-Sylmar

Job: EN-Quality Assurance Engineering

Schedule: Full-time

Shift: Day Job

Travel: Yes, 10 % of the Time

JOB FAMILY:

Engineering

DIVISION:

CAHF Cardiac Arrhythmias & Heart Failure

LOCATION:

United States > Sylmar : 15900 Valley View Court

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

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