Sr. Manufacturing Engineer

1223 Cardiovascular Systems Inc; Houston (TX); On-site; USD 78,000 - 156,000; Full time

Benefits offered by this job

Free medical coverage

retirement plan with employer contrib

Tuition reimbursement

Student debt program

Job summary

Abbott in Houston, TX is seeking a Manufacturing Process Development Specialist to design and develop manufacturing processes for life sciences products within FDA-regulated environments.

You will lead IQ/OQ/PQ protocols, develop PFMEA and DOE studies, and drive Lean Six Sigma to improve yield and reduce scrap. Collaboration with Quality, Regulatory Affairs, R&D, and Supply Chain is essential to ensure scalable, compliant manufacturing solutions.

Qualifications

• Bachelor's degree in Engineering/Technical discipline or equivalent
• Master's degree preferred
• Minimum 5 years relevant experience
• Strong knowledge of ISO13485 and FDA regulations
• Experience with design for manufacture of medical devices and low-cost high-volume electronics

Responsibilities

• Design and develop manufacturing processes for life sciences products.
• Lead IQ/OQ/PQ protocols for medical device manufacturing.
• Develop PFMEA, DOE, and Process Characterization studies for regulatory compliance.
• Drive Lean Six Sigma and continuous improvement initiatives to improve yield and reduce scrap.
• Collaborate with Quality, Regulatory, R&D, Manufacturing, and Supply Chain to enable scalable manufacturing.

Skills

Engineering principles

Design controls

Regulatory knowledge (ISO/FDA)

Communication skills

Medical device processes

DOE and problem solving

Education

Bachelor's degree in Engineering/Technical

Master's degree

Job description

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: www.abbottbenefits.com.

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.

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.

Job Details

Job Family: Manufacturing

Division: AVD Vascular

Location: United States > Texas > Houston : 14740 Kirby Drive

Additional Locations: Not specified

Work Shift: Standard

Travel: Not specified

Medical Surveillance: No

Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Salary

The base pay for this position is $78,000.00 - $156,000.00. In specific locations, the pay range may vary from the range posted.

Equal Opportunity & Diversity

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

About Abbott

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential - because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions - across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

Contact

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

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