Manufacturing Process Development Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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

The position of Manufacturing Process Development Engineer is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine.

In this role you will be responsible for supporting product development from concept through sustained manufacturing of FDA regulated products. Support of process development and equipment acquisition. Experience with manufacturing processes, quality/cost savings initiatives and implementation of engineering principles while assuring compliance with cGMP, quality and safety standards.

SCHEDULE: First Shift

What You’ll Work On

• Responsible for process development, equipment specification, acquisition and implementation.
• Works to identify root cause of manufacturing failures using structured problem solving. Applies root cause fixes to prevent reoccurrence.
• Evaluates machine logic, electromechanical systems and process controls to troubleshoot equipment.
• Completes design of experiments, validation, completion of testing and analysis of data for continuous improvement activities. Presents data to equipment teams.
• Suggests and supports new methods or materials for continual improvement of quality and efficiency.
• Analyzes 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 procedures.
• Works with other engineers and technicians in developing solutions and improvements in materials, equipment and process as necessary.
• Participates in teams as necessary to ensure continual improvement, safety and compliance.
• Provides training and process expertise for product processing in specific areas such as process development, tooling development and validation.
• Manages engineering project teams and coordinates activities.  Mentors junior engineers and maintenance technicians.
• Initiates and works to resolve Quality Incidents and CAPA.
• Ability to travel up to 25% of the time.

Required Qualifications

• Bachelor's degree (BS) in engineering or equivalent combination of education and experience.
• Minimum three years engineering experience in a manufacturing environment.
• Familiarity with a variety of material testing and measuring methods.
• Knowledge of Database software; CAD software; Development software; Internet software; Inventory software; Manufacturing software; Project Management software; Microsoft Excel software and Microsoft Word software.

PREFERRED QUALIFICATIONS:

• Experience working in a GMP, FDA, ISO and USDA regulated environment.
• Familiarity with cGMP and ISO 13485 regulations and practices.
• Familiarity with stati