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
• 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.

Basic qualifications | education:

• 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; MS Excel software and MS 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).

Competencies:

• Ability to work with mathematical concepts such as ANSI/AQL, probability and statistics.