Associate Design Quality Engineer

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 114,000 colleagues serve people in more than 160 countries.

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.

Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents

Our location in Temecula, CA, currently has an opportunity for an Associate Design Quality Engineer.

THIS IS AN ONSITE DAILY POSITION.

WHAT YOU’LL DO

In this role you will actively participate in product development and transfer activities, ensuring product and process conformance to FDA and ISO 13485 standards. Review validation methods and protocols, test methods, statistical analysis methods and specification derivation and assignment. Review new and modified product designs for quality characteristics; including manufacturability, service ability, and conformance to product requirements.

RESPONSIBILITIES:

· Provides design assurance support in design and development of medical device products and facilitate the application of design controls and risk management.

· Acts as a reviewer and approver of validation methods and protocols, test methods, statistical analysis methods and specification development.

· Reviews new and modified product designs for quality.

· Ensures that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and Medical Device Directives.

· Acts as a key contributor to development and validation plans and processes.

· Acts as a key team member in establishing, communicating and mitigating risks.

· Ensures successful transfer of new products to manufacturing.

· Reviews production validation methods.

· Reviews and approve verification and validation test plans.

· Reviews design history files and technical files for conformance to applicable requirements.

BASIC QUALIFICATIONS | EDUCATION:

· Bachelors’ Degree in Engineering (Electrical Engineering degree preferred but not required), or related field, or the equivalent combination of education and experience

· 0-2+ years’ related experience and/or training in a Quality and/or Development Position.

PREFERRED QUALIFICATIONS:

* Medical Devices experience preferred.

* Prior experience in compliance management within a rapid-growth, dynamic organization.

COMPETENCIES:

· Working knowledge of FDA, USDA and applicable non-US regulations pertaining to medical or pharmaceutical manufacturing

WHAT WE OFFER :

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

• A fast-paced work environment where your safety is our priority
• 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 time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being 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

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.

The base pay for this position is $50,000.00 – $100,000.00. In specific locations, the pay range may vary from the range posted.

• fda compliance
• iso 13485 standards
• design assurance
• risk management
• statistical analysis
• validation methods
• product development
• quality characteristics
• manufacturability assessment
• serviceability assessment
• design controls
• verification testing
• validation testing
• technical documentation
• team collaboration
• communication skills