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Collins McNicholas

Title: Manufacturing Engineer (NPI)

Purpose of Job: 

To provide project management and technical input for project planning, equipment specification, process characterization and validation.  Work in close liaison with other departments to ensure product requirements of quality, quantity, mix and cost are achieved.

Major Duties and Primary Responsibilities:

Manufacturing Quality

  • To manage and co-ordinate technical support for the introduction of new products, in line with marketing plans. 
  • Develop resource allocation and a critical path so as to effectively manage the introduction of technology on lines, modifications and process improvements. 
  • Develop manufacturing technical capabilities and skills so as to ensure ongoing process requirements can be effectively achieved. 
  • Actively contribute to the enhancement of compliance initiatives for areas of responsibility. 
  • Develop strong links with our sister plants so as to ensure effective ongoing transfer and sharing of products, processes and systems. 
  • In response to in-house quality levels and product complaints, develop process improvement projects so as to achieve the highest quality standards. 
  • Generate Process and Test method validation protocols and reports. Ensure that process validations and work methods are adequate to maintain the highest quality standards. 
  • Through effective information flow and interaction, develop harmonious working relationships within engineering and other functions, and ensure employees within manufacturing engineering have the necessary information and resources to effectively perform their jobs. 
  • Ensure safety standards and awareness within the manufacturing/process engineering group are in compliance with legislation and issues effectively dealt with. 
  •  To prepare technical documentation such as standard operating procedures, safety programmes, validation protocols, technical reports, engineering calculations, change controls and other documentation as required. 
  •  To provide technical leadership and structured approach to problem solving for operations personnel involved in process engineering and development activities. 
  •  To present, where appropriate, technical data to internal / external audit and inspection groups as required. 
  • Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation. 
  • Will comply with all relevant training required and adhere to relevant associated documentation. 
  • Follow strict adherence to the requirements of cGMP. 
  • Actively contribute to the enhancement of compliance initiatives for areas of responsibility. 

Requirements:

 Education:

  • Minimum of Degree in relevant engineering discipline.

Experience:

  • Minimum five (5) years experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments.

 Skills:

  • Ability to share technical expertise with colleagues i.e. able to express information clearly and concisely both verbally and in written format. 
  • Good problem solving abilities – able to identify facts, consider a number of alternative approaches and evaluate the most appropriate course of action. 
  • Team and results orientated – committed and energetic approach to work with positive attitude. 
  • Proven reliability – efficient, results-orientated and manages own time well. 
  • Ability to deal effectively with all employees and external business contacts while conveying a positive, service-oriented attitude. 
  • Six Sigma/lean expertise demonstrated in the manufacturing, process development and validation of new products is highly desired.
  •  Good interpersonal and communication skills.
  • Ability to work to tight project timelines and within approved budgets.

For a confidential discussion on the role, please contact David Lennon on 0906478104 or david.lennon@collinsmcnicholas.ie

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