Manufacturing Engineer II
Company: Spectraforce Technologies
Location: Westbrook
Posted on: April 23, 2024
Job Description:
Job Title:Manufacturing Engineer II
Job Duration: 5+Months
Job Location:Westbrook, ME
Shift - Mon - Fri (8AM - 5PM)
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. 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.
If you seek a dynamic role where your contributions will pave the
way in developing new products, systems, and processes, come work
with us!
This job description will be reviewed periodically and is subject
to change by management.
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; 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).
Keywords: Spectraforce Technologies, Portland , Manufacturing Engineer II, Engineering , Westbrook, Maine
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