Senior Manufacturing Process Engineer

Abbott • Temecula, CA

1d • $78,000 - $156,000 • Onsite

About The Position

This position works out of our Temecula, CA location in the Abbott Vascular Devices division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease. The role is responsible for developing new manufacturing processes, equipment and materials for use in production of medical devices. The engineer will work on process engineering problems of diverse scope, exercise judgment and define methods and criteria in conducting process engineering experiments and reports results. They will also develop networks with internal/external working relationships in their area of expertise.

Requirements

• Bachelors Degree (± 16 years) in Engineering/Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred) or an equivalent combination of education and work experience.
• Masters Degree (± 18 years) is ideal.
• Minimum 4 years of relevant experience.
• Solid knowledge of general Engineering principles.
• Good knowledge of design controls and regulations for medical device development, (ISO134851, ISO13485, FDA).
• Strong technical experience in mechanical or chemical engineering with excellent written and verbal communication skills are essential.
• Strong understanding of processes and materials used in the development and manufacturing of medical devices, particularly diabetes strips.
• Experience in performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis.
• Experience working in a development environment with a disciplined process/product development process.
• Experience writing process/product requirements and design specifications.
• Experience working on a development team with an emphasis on minimizing time to market.
• Experience in design for manufacture of low cost, high volume electronic products.
• Experience in development of processes in an FDA regulated environment with full understanding of GxP, ISO and medical device regulations.
• Experience in cross functional team environments is required.

Responsibilities

• Specify, design, verify and validate new manufacturing processes and equipment, in accordance with applicable medical regulatory standards.
• Troubleshoot process equipment and perform process optimization.
• Develop process/product specifications, conduct pFMEAs, DOEs, validation protocols/reports and other associated documentation following design control requirements.
• Communicate effectively and participate on cross functional development teams.
• Conduct or participate in technical design reviews for process equipment and product design and requirements documents.
• Write and submit Engineering Change Orders, as required.
• Responsible for utilizing and maintaining the effectiveness of the quality system.
• Development and implementation of new processes, equipment, materials, verification and validation.
• Follow approved Design Control procedures for process development in accordance with FDA guidelines.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior