Manufacturing Engineer II - Westbrook, United States - Astrix Inc

Description

Our client, a global healthcare leader whose portfolio of life-changing technologies spans the spectrum of healthcare, is looking for a Manufacturing Engineer II to join their growing team With an innovative product range from diagnostic and generic medications to medical devices and beyond, you will have the opportunity to grow your career and make a true difference

The position of

Manufacturing Engineer II

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.

JOB RESPONSIBILITIES:
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.


JOB 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.
Knowledge of Database, CAD software
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).
Ability to work with mathematical concepts such as ANSI/AQL, probability, and statistics.

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