Sr. Manufacturing Engineer

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.

Specialist professional individual contributor with comprehensive knowledge in the area of Manufacturing Process Development. Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions.

What You'll Work On

• As the Specialist in the Manufacturing Process Development Sub-Function, considered as 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.
• 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.

Required Qualifications

Education: Bachelors Degree (± 16 years) Engineering/Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred) or an equivalent combination of education and work experience. Masters Degree (± 18 years).

Ideal Experience: Minimum 5 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.