About the position
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. 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. 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.
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.
Requirements
- 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.
Nice-to-haves
- Medical Devices experience preferred.
- Prior experience in compliance management within a rapid-growth, dynamic organization.
Benefits
- Career development with an international company.
- Free medical coverage in the Health Investment Plan (HIP) PPO medical plan.
- Excellent retirement savings plan with high employer contribution.
- Tuition reimbursement and FreeU education benefit.
- Recognition as a great place to work in dozens of countries.
- Fast-paced work environment with safety as a priority.
- Training and career development with onboarding programs.
- 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.
