Tekna Inc. is seeking a manufacturing engineer for its Kalamazoo, Mich., operation.
Job Description
The primary purpose of this position is to develop and maintain robust, cost effective assembly processes and related documentation for use throughout the manufacturing facility, which is consistent with Tekna’s quality and manufacturing excellence goals and objectives. The manufacturing engineer's role at Tekna is to ensure Tekna’s internal and external customer expectations are met or exceeded.
DESIRED SKILLS AND EXPERIENCE
Essential Job Functions
• Evaluate existing manufacturing lines including time studies, line layouts, component design, equipment, tools, fixturing, etc. to improve productivity, obtain cost reductions, and improve quality.
• Resolve manufacturing and supplier nonconformities with sound and long-lasting corrective actions.
• Work with suppliers to improve components, reduce cost, and correct problems.
• Provide technical expertise and support to manufacturing personnel.
• Write, update, and approve manufacturing processes.
• Train manufacturing processes.
• Assist in evaluation of personnel’s competency of manufacturing processes.
• Plan line layout and determine equipment requirements for new products.
• Review and approve drawings for new components and products.
Product testing
• Participate in risk management activities.
• Participate in internal and external audits.
• Assist in evaluation and corrective action for returns and customer complaints.
• Assist with process validations.
• Perform other functions as required.
Position Qualifications
Minimum Education: Bachelor’s degree in Manufacturing Engineering, Mechanical Engineering, Engineering Design Technology, or similar.
Minimum Experience
3+ years of experience in manufacturing engineering role.
Specialized Knowledge
• Computer skills as required by stated accountabilities. Intermediate word-processing and spreadsheet skills.
• Excellent problem solving skills.
• Solid knowledge of engineering fundamentals and a proven ability to apply this knowledge in manufacturing and new product development.
• Familiarity with 21CFR820, ISO 13485, and ISO14971 is a plus.
Special Skills
Strong written and oral communication skills. Demonstrated ability to work in a team environment and solve conflicts. Intermediate skill level in Pro-E Wildfire.
Company Description
Tekna designs, develops and manufactures medical products for world class medical device companies. Tekna’s manufacturing and distribution capabilities allow it to complete the entire development process from concept to distribution. It is a small company on a growth path. Its quality management systems play a significant role in the development and realization of products. It ensures its success in part by complying with ISO13485 and FDA QSR.
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