Manufacturing Process Engineer II at Abbott

Westfield, Indiana, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Knowledge of Design for Manufacturability (DFM) principles
Proficiency in problem solving and statistical tools
Understanding of Quality requirements (e.g., Design Control, Process validation)
Awareness of work environment issues (e.g., OSHA regulations)
Familiarity with Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements (e.g., ISO, FDA, cGMP)
Ability to conduct tests, collect and format data, and assist in analysis of engineering studies (DOEs)
Capability to assist in startup of new equipment and execution of validation protocols
Experience participating in technical design reviews for process equipment and product design
Knowledge of raw material specifications and evaluation of changes
Compliance with U.S. Food and Drug Administration (FDA) regulations, Company policies, and operating procedures

Responsibilities

Develop processes based on product specifications, considering process and test method capabilities
Evaluate process and design alternatives
Make sound design recommendations
Manage program compliance with Quality requirements
Support Company initiatives in QMS, EMS, and regulatory compliance
Identify work environment issues
Assist in analysis of engineering studies
Assist in startup of new equipment and execution of validation protocols
Participate in technical design reviews for process equipment and product design
Utilize and maintain the effectiveness of the quality system, including supporting Quality Incidents and CAPA investigations
Analyze raw material specifications to ensure appropriate features and limits
Evaluate company-initiated raw material changes and coordinate testing and validation
Reduce costs in manufacturing by analyzing equipment and providing improvement plans
Create and revise manufacturing documents, SOPs, safety instructions, validation protocols, risk assessments, and procedures
Conduct preventative maintenance audits and ensure compliance with SOPs, ISO, FDA, and cGMP
Research engineering solutions to production and development challenges
Responsible for all manufacturing equipment and equipment quality/cost savings initiatives
Improve efficiency through material and process improvement
Reduce material processing costs
Participate in new product design

Skills

Manufacturing Processes

Process Development

Equipment Maintenance

Quality Improvement

Cost Reduction

Material Processing

Product Specifications

Lean Manufacturing

Six Sigma

Process Validation

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees