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
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.
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