Electrical Development Quality Engineer II

Abbott•Los Angeles, CA
•$81,500 - $141,300•Onsite

About The Position

Our location in Sylmar, CA currently has an opportunity for an Electrical Development Quality Engineer II. This is a fully onsite role. A Development Quality/Design Assurance Engineer assures new or modified products conform to quality standards and establishes 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. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.

Requirements

  • Bachelor’s Degree in Engineering or Technical Field or an equivalent combination of education and work experience.
  • 2 years of quality engineering experience and demonstrated use of Quality tools/methodologies
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • 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 travel approximately 10%, including international.

Nice To Haves

  • Masters Degree

Responsibilities

  • Execute and support on-time completion of Design Control Deliverables.
  • Accountable for Electrical Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities.
  • Lead or support Risk Management activities from product Concept through Commercialization.
  • Support electrical 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 audits and 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 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.

Benefits

  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
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