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Manufacturing Engineer
2 months ago
The Manufacturing Engineering is to in close collaboration with Operations, NPI Engineering, Design & Development, and Purchasing to support Catheter Manufacturing for the Operations team. You will be involved in the design and development of fixtures and processes to scale manufacturing of catheters. You will be responsible for documentation, and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on process and efficiency improvements, clinical builds, training production, preparation, and execution of process validation for new version of products.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Develops and implements robust cost-effective manufacturing processes, and improves product flow and product quality and safety performance for both sustained and new products.
Leads assigned customer transfer of new products to production including establishing assembly time and yield targets, training needs and quality control.
Develops, tests and implements tools, fixtures and equipment required for manufacturing processes.
Develop and maintain manufacturing process instructions, inspection plans and lot history travelers.
Leads creation of manufacturing process validation plans, validation protocols and reports, and implements manufacturing process validations and test method validations.
Collaborates with cross-functional teams including customer during development phase(s), and provides inputs and recommendations for design for manufacturability (DFM).
Maintains process risk documentation (e.g. PFMEA) to identify potential risks, and implement preventive and corrective actions
Manages and/or supports production and test equipment maintenance, qualification and calibration.
Performs analysis for cost reduction, and quality and efficiency improvement.
Prepares engineering change orders and coordinates the implementation of changes including training production staff.
Troubleshoots designs and processes when defects occur, leads investigation to determine root cause and implements effective containment and counter measures.
Dispositions non-conforming products and develops required re-work procedures and processes.
Communicates with customers regarding process improvements, fixture development, and production changes
Perform other responsibilities duties as assigned.
This is not a remote position. The position requires to work onsite and support the production floor daily.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
REPORTING STRUCTURE
This position reports to the Operations Manager.
SUPERVISORY RESPONSIBILITY
n/a
REQUIRED EDUCATION, EXPERIENCE, SKILLS AND KNOWLEDGE
BS in Mechanical / Biomedical / Industrial Engineering or in an equivalent engineering discipline
3-5+ years of experience in catheter based medical device process development and/or manufacturing engineering
Experience with lean manufacturing techniques, value stream mapping, and continuous improvement methodologies highly preferred
Experience with new product introduction and interactions daily with customers development teams
Solid knowledge of GMP and ISO 13485 regulations
Must be able to review and interpret technical drawings and specifications. Proficiency in Solidworks preferred.
Strong computer skills, including the MS Office suite
Must be able to read, write and speak fluent English, and must possess excellent communication and presentation skills, both written and oral
Must have demonstrated organizational skills to manage multiple priorities and schedules.
CORE COMPETENCIES
Communication Skills
All verbal and written communications are concise, technically accurate, timely, and professional. Demonstrates strong verbal presentation and negotiation skills. Represents in a positive and professional manner. Expresses ideas, recommendations and solutions clearly, logically and concisely in both written and verbal communications. Demonstrates tact and diplomacy in communications. Demonstrates active listening skills and ability to resolve discrepancies with customers
Management of Resources
Well organized and uses time efficiently. Familiar with all reference materials and can locate needed information as necessary. Takes initiative for self-development. Prioritizes tasks effectively. Demonstrates initiative and creativity in the use of available resources.
Customer Focus
Provide professional, reliable and prompt service to internal and external customers Work in partnership with others to meet and exceed customer expectations. Interpret customer needs and take appropriate action. Follow through on customer inquiries in a professional and timely manner.
WORKING CONDITIONS / PHYSICAL DEMANDS
Must be able to move throughout office and laboratory space, using a complete variety of office equipment and laboratory machinery, and tools. May lift up to 30 pounds and stand for extended periods of time. Must tolerate exposure to chemicals found in the Meraqi Medical Inc environment.
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