Apply Now

Job ID: JOB-13586

Manufacturing Engineer II 

Responsibilities

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling, fabrication of tools and equipment.

• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout

• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.

• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.

• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

• Develops automated solutions through engagement with automation integrators and vendors

• Leads and manages automation integration projects utilizing sound project managing principles and documentation

• Leads and executes validation compliance activities including design, FAT, SAT, IQ, OQ, PQs in compliance with FDA CFR 21 part 11 and other relevant parts

• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.

• Implement statistical process control, OEE and process efficiency measurement and improvement tools.

• Ensures processes and procedures are following regulations. #IJ

Key Skills & Experience

• Level 8 or higher qualification in Mechanical, Polymer, Biomedical or related Engineering /Science discipline

• Requires minimum of 2 years of relevant experience in a highly regulated environment, typically MedTech / Pharma / Plastics processing environments.

• Requires broad knowledge of manufacturing processes and systems, techniques and practices typically gained through extensive experience and/or education.

• Working knowledge of Extrusion, Blow moulding or Injection moulding, Automation and robotics.

• Application of statistical and analytical methods such as SPC, SQC, and DOE.

• Experienced in working with DFA (Design for Automation), Lean Sigma, Analytical packages incl. Minitab.

• Development of manufacturing documentation (MP, IP, BOM, CDP, IQ, OQ, PQ).

• Leading project teams tasked with process improvements, material changes, automation, validation, CAPA, continuous improvement activities, training, and varied manufacturing engineering activities.

• A dynamic team player who can work effectively and proactively on cross-functional teams. An effective and creative problem solver.

For further information on this role in please contact on Gavin Moran on 087 4108620 or connect@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Gavin Moran

JOB-13586

Apply Now