Electrical Development Quality Engineer II

Regulatory Jobs; Los Angeles (CA); On-site; USD 82,000 - 141,000; Full time

Job summary

Abbott in Sylmar, CA, is seeking an Electrical Development Quality Engineer II to ensure products meet quality standards and regulatory requirements. This on-site role collaborates with cross-functional teams to protect patient safety and support product development from concept through commercialization.

The position requires a Bachelor's in engineering or technical field and at least 2 years in quality engineering, with strong communication and ability to work in a matrixed environment.

Qualifications

• 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 in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse environment.
• Strong verbal and written communications; effectively communicate at multiple levels in the organization.

Responsibilities

• Execute and support on-time completion of Design Control Deliverables.
• Accountable for Electrical Design Verification and Validation planning & execution, including cross-functional root-cause analysis and resolution.
• 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; communicate and resolve 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 establishment of objective, measurable product requirements and supplier qualifications.
• Complete Document Change Request Reviews in a timely and objective manner.

Education

Bachelor’s Degree in Engineering or Technical Field

Master’s Degree

Job description

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• 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.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

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.

WHAT YOU’LL DO:

• 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.

Required Qualifications

• 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.

Preferred Qualifications

• Masters Degree

The base pay for this position is

$81,500.00 – $141,300.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

CRM Cardiac Rhythm Management

LOCATION:

United States > Sylmar : 15900 Valley View Court

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % 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), 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.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf