Our client, a medical device company in Westmeath are currently looking to recruit an Advanced Manufacturing Engineer for their site.
Summary of Position:
The Advanced Manufacturing Engineer (AME) champions the manufacturability of new product introductions from product design to the manufacturing process and is accountable for the practical application of design for excellence principles on the product/process development efforts. This position is also responsible for the formalization, coordination and implementation of product test strategies into manufacturing.
Reporting to Operations, this position is based in Carlsbad, CA.
- Work as part of the development team to bring new products to market on time; in budget and within predetermined specifications.
- Is a core team member on the product development process (PDP) teams representing operations (Eng., Mfg., Procurement, Logistics) and is accountable for leading manufacturing core teams during the different PDP phases.
- Accountable for key operations related deliverables within the (PDP) including but not limited to Mfg. Plan; Make/Buy decision analysis/recommendation; Capacity Planning; COGS estimation; Process Validation; Prototype Builds; Capital Equipment Specifications and Procurement; etc.
- Responsible/contributor for operations related activities and tasks within the PDP.
- Is a consultant on inquiries posted by team members related to manufacturing and testing technologies or other operations related processes.
- Accountable for the application of Design for Excellence (DFX) principles such as DFM; DFC; DFQ; DFT.
- Application of OpEx methodologies such as Six Sigma and LEAN to identify, validate and improve defect sources in a variety of business processes.
- Application of risk management methodologies such as DFMEA and PFMEA to identify actions that can be taken to eliminate or reduce the potential causes leading to failures.
- Procure and manage contractors.
- Accountable for the development of product test strategies interfacing with the receiving manufacturing site.
- Understanding receiving plant test capabilities
- Evaluating any potential for contracting test fixture development
- Driving test strategy realization and schedule with receiving plant
- Adhere to SOP's and have the ability to prepare written policies, procedures, proposals, and reports in accordance with cGMP/FDA/ISO-13483 guidelines and regulations.
- B.S. Mechanical Engineering
- Strong record of manufacturing (mfg.) operations management experience including:
- Mfg. process management involving a collection of technologies and methods used to define how products are to be manufactured
- End-to-end manufacturing process involving production management, performance analysis, quality and compliance.
- A minimum of 10 years manufacturing engineering experience in a medical device, pharmaceutical or related industry, with a demonstrated track record of developing processes for new products including experience in Plastics Processing Mfg. Technologies (Molding, Extrusion, Assembly of consumable medical devices)
- Knowledge of business and management principles involved in strategic planning, resource allocation, leadership technique, production methods, and coordination of people and resources.
- Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
- Experience with industrial engineering processes including takt/cycle times estimates, process flow, line layout, capacity planning.
- Strong Project Management Skills of manufacturing process from concept to delivery.
- Strong Mechanical Aptitude (aptitude for understanding and using machines and/or tools).
- Six Sigma/Lean certified preferred.
- Ability to prepare written policies, procedures, proposal, and reports.
- Well versed in Design for Excellence (DFX) Principles.
- Knowledgeable in risk management methodologies such as DFMEA and PFMEA.
- Knowledgeable in manufacturing plant test strategies.
- Machining equipment experience preferred.
- Solid Works, AutoCAD, MS Office, MS Project.
Effective communication skills with superiors, peers and subordinates
For further information on this Advanced Manufacturing Engineer role in Westmeath please contact Deirdre Finnerty on 091730022 / email@example.com
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