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Sr. Manufacturing Engineer

Job in Houston, Harris County, Texas, 77246, USA
Listing for: 1223 Cardiovascular Systems Inc
Full Time position Listed on 2026-11-15
Job specializations:
Salary/Wage Range or Industry Benchmark: 78000 - 156000 USD Yearly USD 78000.00 156000.00 YEAR

Job Description & How to Apply Below

Job Description

Working 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.

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.
  • 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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

The Opportunity

This position works out of our Houston, TX location in the Abbott Vascular Devices division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.

What You'll Work On

As the Specialist in the Manufacturing Process Development sub-Function, you will be a highly experienced and knowledgeable resource within the organization in designing and developing manufacturing processes for life sciences products, taking into consideration problems inherent in the transfer of technology from research to manufacturing. Such design and development may include new or revised processes.

Develops procedures for the economical mass production in cooperation with pilot-plant and production departments. Conducts tests and measurements throughout stages of production to determine control over applicable variables. Services, troubleshoots and solves production process problems with processes or equipment already in operation. Requires understanding of compliance, pharmaceutical, pharmacological, biological, biochemical, medical, patent and commercial factors.

May make recommendations concerning acquisition and use of new technological equipment and materials. Lead equipment and manufacturing process qualification activities, including development and execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in support of medical device manufacturing operations. Develop, execute, and maintain process validation documentation, including Process Failure Mode and Effects Analysis (PFMEA), Process Characterization studies, Design of Experiments (DOE), and Test Method Validation (TMV) documentation to ensure regulatory compliance and robust process performance.

Drive Lean Six Sigma and continuous improvement initiatives through data-driven problem solving, root cause investigations, and implementation of corrective and preventive actions to improve yield, reduce scrap, and increase operational efficiency. Utilize statistical analysis and process control methodologies to optimize manufacturing processes, establish process capability, monitor performance metrics, and support CAPA activities.

Partner with cross-functional teams including Quality, Regulatory Affairs, R&D, Manufacturing Operations, and Supply Chain to support new product introductions, product transfers, process validations, and manufacturing excellence initiatives within FDA-regulated environments. Support development and implementation of process controls, validation strategies, and risk mitigation plans to ensure compliant, scalable, and sustainable manufacturing processes.

Req…
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