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Job Information

Abbott Mechanical Development Quality Engineer I in Sylmar, California

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. This position will be located in our Sylmar , CA office.

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

Summary:

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.

WHAT YOU’LL DO

  • 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 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.

EDUCATION AND EXPERIENCE YOU’LL BRING

  • 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%, 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

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development , with onboarding programs for new employees and tuition assistance

  • Financial security through competitive compensation, incentives and retirement plans

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

  • Paid t ime off

  • 401 ( k ) retirement savings with a generous company match

  • The stability of a company with a record of strong financial performance and history ofbeing actively involved in local communities

*Learn more about our benefits that add real value to your life to help you live fully: * www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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