Process Engineer II

HERO

Job Detail

Location Clonmel Tipperary
Salary Negotiable
Posted
Role Type Permanent
Contact Andrin Kraja
email Recruiting@hero.ie

Process Engineer II

Apply Now

Job ID: JOB-13196
Purpose 

Responsible for providing mechanical engineering support in the creation and the development of new medical device products (invasive and non-invasive). Interfaces with Design, Quality and Manufacturing organizations to integrate new products, equipment sets or processes into production. 

Responsibilities 

  • Researches, develops, designs, and evaluates mechanical and electro-mechanical materials, components, assemblies, processes and/or equipment.
  • Conducts feasibility studies to verify capability and functionality.
  • Develops new concepts from initial design to market release.
  • Write and submit intellectual property (patents).
  • Maintains detailed documentation throughout all phases of development.
  • Working as part of the Process Development group this person will aid design of new equipment for new products & manufacturing. This person will play a key role in the design phase of the equipment from initialisation to final handover.
  • Work closely with machine Vendors in order to ensure that the equipment is designed, built & tested according to the companies specifications and is properly handed over to manufacturing.
  • Experience with working with Laser Systems & Laser materials processing (Welding, Marking, Cutting, etc) an advantage.
  • Knowledge in CNC code or CADCAM would be beneficial.
  • Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
  • Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
  • Plans, organizes, and conducts all aspects of technical reviews.
  • Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.).
  • Reviews or coordinates vendor activities to support development.
  • Demonstrates strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of “waste” process steps and development of efficient, cost effective equipment and processes.
  • Demonstrates strong knowledge and application of Process and equipment validation techniques (IQ, OQ, PQ), PFMEA’s, and associated regulatory requirements and applies this knowledge in the efficient & timely validation of equipment and processes.
  • Co-ordinates execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results.

Qualifications/Experience:

  • Level 8 engineering degree qualification 
  • 3+ yrs engineering experience in a GMP environment 

 

Andrin Kraja

JOB-13196

Apply Now

Process Engineer II

Andrin Kraja

Role Type Permanent
Contact Andrin Kraja
email Recruiting@hero.ie
mobile +086 107 1395
linkedIn profile click here

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