Advanced Manufacturing Engineer

As our Advanced Manufacturing Engineer your Key Accountabilities will include:

• 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.
• 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.
• 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.

As Advanced Manufacturing Engineer your Skills & Qualifications will include:

Minimum requirements;

• As our Advanced Manufacturing Engineer your Key Accountabilities will include:
• 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.
• 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.
• 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.

As Advanced Manufacturing Engineer your Skills & Qualifications will include:

Minimum requirements;

• BS Degree in Mechanical Engineering
• 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 (Moulding, Extrusion, Assembly of consumable medical devices)
• Strong record of manufacturing (mfg) operations management experience including:

a) mfg. process management involving a collection of technologies and methods used to define how products are to be manufactured

b) end-to-end manufacturing process involving production management, performance analysis, quality and compliance.

• 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.
• Knowledge of business and management principles involved in strategic planning, resource allocation, leadership technique, production methods, and coordination of people and resources.
• Strong Mechanical Aptitude (aptitude for understanding and using machines and/or tools).

Preferred requirements:

• 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.

Other skills:

• Machining equipment experience preferred.
• Solid Works, AutoCAD, MS Office, MS Project.
• Effective communication skills with superiors, peers and subordinates

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