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Electrical Development Quality Engineer II

Company: Abbott Laboratories
Location: Sylmar
Posted on: June 13, 2021

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.

A healthy heart is essential to good health. That's why we're committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people's health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Our location in Sylmar, CA currently has an opportunity for a Electrical Development Quality Engineer II.

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.

WHAT YOU'LL DO

  • Responsible for the proper prediction of, and the ultimate product performance of, the electrical system

  • Evaluate 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

  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP) and design change projects

  • Prepare risk management files and report for product releases and have responsibility for active participation in risk management activities from product conception through commercialization

  • Support design test & inspection method development and execute method validation activities

  • Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps

  • Support and ensure internal & external audit responses

  • Support product re-certifications

  • Support and ensure 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

  • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors and vendors

  • Perform other related duties and responsibilities, on occasion, as assigned

EDUCATION AND EXPERIENCE YOU'LL BRING

Required

  • 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 maintain regular and predictable attendance

Preferred

  • 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

Keywords: Abbott Laboratories, Los Angeles , Electrical Development Quality Engineer II, Other , Sylmar, California

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