Essential Duties and Responsibilities:
The Manufacturing Engineer will be a contributing member of Operation Manufacturing team that responsible for product development manufacturability of Products and Processes at the company`s Suppliers and Manufacturing sites. Manufacturing Engineer will work as a team member with the Operation Manufacturing team, Quality and R&D organizations to ensure the successful transfer and ongoing production of finished Medical Devices at company`s Contract Manufacturing sites. Applicant must demonstrate the ability to deliver good communication, quality, innovative, manufacturability, cost-effective and timely solutions in a multiple project environment.
• Medical device experience
• Introduction of new Product and Process into manufacturing
• Performing measurements and statistical analysis to support project activities
• Contributing to engineering designs to support project activities
• Develop and execute engineering test requirements and protocols for components and devices. Instructs engineers and technical support staff on engineering test.
• Provides written reports and engineering documentation
• Assures compliance with company Standard Operating Procedures and policies
• Demonstrates knowledge and understanding of Good Manufacturing Practices and all other applicable standards
Job Qualifications:
• Ability to write engineering documents, test protocols and reports
• Managing and developing engineering changes in a medical manufacturing environment
• Self-starter with go get it attitude and strong interpersonal skills
• Strong MS Office skills
• Effective oral and written English communication skills
• Strong writing skills (Supplier Qualification requirements, Mfg. Instruction creation etc.)
• Supplier quality issue resolution
• Experience in the regulatory requirements of medical devices including EMC, safety, and RoHS.
• Working knowledge in Lean and Six-Sigma methodologies
• Works directly with suppliers and contract manufacturing in all aspects of Product and Process development, release, and sustaining activities
Education
• Required: Bachelor’s degree in Mechanical Engineering or related field.
Experience:
• 2-3 years' experience in engineering practice.
• 2-3 years of experience working in medical device manufacturing
• Demonstrated strong planning and organizational skills
• Experience working with FDA Quality Systems Regulations and ISO Quality Systems.
• Familiarity with SPC, Product Design, Process validation, and Lean manufacturing/Six Sigma concepts and understanding.
• Strong MS Office skills
Working Environment:
Usual office environment with frequent (Between once and twice a week) visit at suppliers and contract manufacturing.
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