Senior Manufacturing Process Engineer

The Opportunity

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.

Responsible for developing new manufacturing processes, equipment and materials for use in production of medical devices. Works on process engineering problems of diverse scope Exercises judgment and defines methods and criteria in conducting process engineering experiments and reports results Develops networks with internal/external working relationships in area of expertise

? Specify, design, verify and validate new manufacturing processes and equipment, in accordance with applicable medical regulatory standards.

? Troubleshoots process equipment and perform process optimization.

? Develops 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.

? Conducts or participates 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.

Education:

Bachelors Degree ( 16 years)

Engineering/Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred)

An equivalent combination of education and work experience

Masters Degree ( 18 years)

Ideal

Experience:

Minimum 4 years

Relevant experience

Solid knowledge of general Engineering principals.

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 all of the following: performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis working in a development environment with a disciplined process/product development process.

Writing process/product requirements and design specifications.

Working on a development team with an emphasis on minimizing time to market.

Design for manufacture of low cost, high volume electronic products.

Development of processes in an FDA regulated environment with full understanding of GxP, ISO and medical device regulations.

Cross functional team environments is required.

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