Manufacturing Process Engineer

4 weeks ago

Scarborough, Maine, United States Abbott Laboratories company Full time

About the Role

Abbott Laboratories is seeking a skilled Manufacturing Engineer I to join our team. In this role, you will be responsible for supporting product development from concept through sustained manufacturing of FDA regulated products.

Key Responsibilities

  • Support 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
  • 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

Requirements

  • 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
  • Ability to work with mathematical concepts such as ANSI/AQL, probability, and statistics
  • 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 statistical analysis software (Minitab)

About Abbott

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.

We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life.

Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

At Abbott, you can have a good job that can grow into a great career. We offer training and career development, with onboarding programs for new employees and tuition assistance. Financial security through competitive compensation, incentives, and retirement plans. Health care and well-being programs, including medical, dental, vision, wellness, and occupational health programs. Paid time off, 401(k) retirement savings with a generous company match. The stability of a company with a record of strong financial performance and history of being actively involved in local communities.

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