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Title: Manufacturing Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Contract – 6 months ++ possibly to permanent
- Pay rate: 30-34/hr.
- Job Location: Danbury, CT
- Job# bh12031
Our client is seeking: Manufacturing Engineer
Description:
Job Summary:
We are looking for a talented Manufacturing Engineer to oversee and improve manufacturing processes for medical equipment. The Manufacturing Engineer's responsibilities include identifying areas for improvement, maintaining high levels of manufacturing and product quality, improving products and processes, and conformance with regulatory standards.
A successful Manufacturing Engineer should be able to work effectively within a team and apply knowledge of product design, fabrication, assembly, tooling, testing, and materials. They should also have a drive for standardizing processes to remove variation and prevent errors, along with the belief that processes of today must be challenged and improved for tomorrow.
Essential Duties and Responsibilities:
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Ability to understand design requirements and be able to create a manufacturing plan
- Hands on knowledge of creating process flowcharts, PFMEA & Process Control plans.
- Facilitate the transfer of design changes from design engineering to manufacturing.
- Performs root cause analysis and recommends corrective actions in response to manufacturing issues.
- Continuously work to improve manufacturing methods, efficiency and product quality.
- Specify and provide all necessary tools, equipment, fixtures, and facilities required for assigned product line.
- Assists in maintaining existing test fixtures and update work instructions as required.
- Manage Software validation and release for production.
- Develop and validate processes for manufacturing as per FDA guidelines. Hands on experience of process validations including IQ, OQ, PQ.
- Define and develop assembly and test methods for assigned product line. Assure that work instructions and drawings are created when necessary.
- Monitor quality reports and field performance of assigned product line, identify trends, investigate problems and implement corrective actions.
- Maintain product sequence and routings
- Serve as interface for key subcontractors. Provide training and assistance, as necessary.
Physical Demands:
The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Sit; use hands to finger, handle or feel objects, tools, or controls.
Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
Lifting/moving and carrying products weighing up to 40 pounds.
Potential Exposure to moving mechanical parts, vibration and/or moderate noise levels.
Potential Exposure to hazardous chemicals or other materials.
Potential Exposure to moving mechanical parts, vibration and/or moderate noise levels.
Potential Exposure to hazardous chemicals or other materials.
Safety Shoes with Impact and Compression Protection Must be worn in designated areas.
Exposure to blood.
Other (please specify): May work with or around high voltage and radiation generating equipment.
Qualifications
Education:
- B.S. Mechanical, Manufacturing, Software, Industrial Engineering
- Also A.S. degree with 6 years of related work experience
Experience:
- Minimum two years’ experience in Manufacturing Engineering and/or Similar
- Medical Device Manufacturing experience preferred
Skills:
- Change Management including verification and validation.
- Security Patch and Software validation.
- Understanding & hands on application of Lean Manufacturing principles preferred.
- Ability to manage projects.
- Experience with computer-aided design preferred.
- LabVIEW experience is preferred.
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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