Sr. Manufacturing Engineer

Abbott (abbottcareers2 board); United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Abbott in Houston, TX seeks a Specialist professional in Manufacturing Process Development to design and develop manufacturing processes for life sciences products, transferring technology from research to production.

You will lead IQ, OQ, PQ protocols, develop validation studies (PFMEA, DOE, TMV), drive Lean Six Sigma improvements, and partner with Quality, Regulatory, R&D, Manufacturing Operations, and Supply Chain to enable scalable, compliant operations in FDA-regulated environments.

Qualifications

• Engineering/Technical discipline in mechanical, chemical, electrical or physics.
• Bachelor's degree and, ideally, a Master's degree.
• Minimum 5 years of relevant experience.
• Strong knowledge of design controls and regulations (ISO13485, FDA).

Responsibilities

• Design and develop manufacturing processes for life science products.
• Lead IQ/OQ/PQ protocols in medical device manufacturing.
• Develop validation docs: PFMEA, DOE, TMV for regulatory compliance.
• Drive Lean Six Sigma and continuous improvement initiatives.
• Collaborate with Quality, Regulatory, R&D, Manufacturing Operations, and Supply Chain.

Skills

Mechanical Engineering

Chemical Engineering

Written and Verbal Communication

Education

Bachelor's Degree (± 16 years)

Master's Degree (± 18 years) Ideal

Job description

Working at Abbott

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.
• 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.

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.

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.

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.

Strong understanding of processes and materials used in the devel

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.