Manufacturing Process Engineer II

Abbott Laboratories-posted 3 months ago
$60,000 - $120,000/Yr
Full-time • Mid Level
Westfield, IN
Computer and Electronic Product Manufacturing
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Manufacturing Process Engineer II at Abbott is responsible for all manufacturing equipment and equipment quality/cost savings initiatives, improving efficiency through material and process improvement, reducing material processing costs, and participating in new product design. This position works out of our Westfield, Indiana location in the Structural Heart division, which aims to restore health and improve quality of life by providing device and management solutions for treating structural heart disease.

  • Develops processes based on product specifications and in consideration to process and test method capabilities.
  • Evaluates process and design alternatives based on Design for Manufacturability (DFM) principles.
  • Uses problem solving and statistical tools and makes sound design recommendations.
  • Manages program compliance with Quality requirements (i.e. Design Control, Process validation etc.).
  • Identifies work environment issues (i.e. OSHA regulations, etc.).
  • Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Conducts tests, collects and formats data, and assists in analysis of engineering studies (DOEs).
  • Assists in start up of new equipment and execution of validation protocols.
  • Participates in technical design reviews for process equipment and product design and requirements documents.
  • Responsible for utilizing and maintaining the effectiveness of the quality system, including supporting Quality Incidents and CAPA investigations and actions.
  • Analyzes raw material specifications to ensure appropriate features and limits are in place to support company manufacturing process.
  • Evaluates company initiated raw material changes and coordinates appropriate testing and validation as required.
  • Works to reduce costs in all areas of manufacturing by analyzing current equipment for process suitability and provides detailed plans for improvement.
  • Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to ensure compliant, efficient, and safe processes.
  • Conducts preventative maintenance audits and compliance with SOPs, ISO, FDA and cGMP requirements.
  • Researches engineering solutions to a diverse set of challenges in production and development.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Bachelor's degree (BS) in Engineering or equivalent combination of education and experience.
  • 3+ years' engineering experience in a manufacturing environment.
  • Technical experience in mechanical, biomedical, industrial or chemical engineering.
  • Experience in performing engineering calculations, controlled tests, statistical analyses.
  • Experience in Microsoft Suites software (Microsoft Excel, PowerPoint, Power BI, etc.).
  • Experience in change management principles and processes.
  • Production ramp up experience.
  • Experience with cGMP and ISO 13485 regulations and practices.
  • Experience with statistical analysis software (Minitab or JMP preferred).
  • Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with a high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit.
  • Career development with an international company.
  • Recognized as a great place to work in dozens of countries worldwide.
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