Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.
The Opportunity
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.
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.
Apply Now
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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- 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.
JOB FAMILY
Manufacturing
DIVISION
AVD Vascular
LOCATION
United States > Texas > Houston : 14740 Kirby Drive
ADDITIONAL LOCATIONS
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)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
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
