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Collins McNicholas

Job Description

Title:    BIFG MANUFACTURING ENGINEER

Purpose of Job:

Oversight of the technical management of external contract manufacturing partner(s). Deliver engineering solutions to the business regarding external contract manufacturers. Lead and/or support engineering projects including process validation, continuous improvement, manufacturing transfer or COGS for Bought-in-Finished-Goods (BIFG).

 

Major Duties and Primary Responsibilities:

  • Partner with BIFG and Quality to achieve required business operational control and agreed service levels regarding Contract Manufacturers (CM).
  • Deliver technical and engineering solutions to the business regarding the process at CM.
  • Collaborate with BIFG to support product availability from CM against build commitment & schedule.
  • Plan, facilitate and execute engineering projects with CM to drive effective cost structures and control.
  • Provide engineering oversight of change control on technical matters, such as process validation and manufacturing transfer……etc., within CM.
  • Lead, coordinate and execute manufacturing transfer of projects on the new product development or/and design change of sustaining products.
  • Actively manage the portfolio of engineering projects within CM.

Detailed responsibilities:

  •  Review and approve supplier change requests and company initiated change requests.
  • Actively manage technical issues within CM using structured methodologies. Activities may include conducting device evaluations related to product / process issues and performance.
  • Provide technical oversight, support and guidance to CM on process development, process validation, test method validation (TMV), risk assessment and design for manufacture (DFM).
  • Partner with BIFG in initiating & driving product cost reduction and continuous improvement strategies with suppliers.
  • Facilitate and drive continuous improvement with CM in terms of product quality and service.
  • Exercise project management discipline on technical projects as appropriate in achieving business objectives.
  • Monitor and control progress of supplier engineering projects, ensure sound application of engineering practices and provide project reviews where necessary.
  • Manage company owned assets at CM sites to ensure appropriate maintenance and obsolescence planning is deployed.
  • Follow strict adherence to the requirements of cGMP.
  • Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
  • Participates in the assessment of feasibility, selection and application of proposed technology initiatives related to CM.
  • Provide technical information on appropriate areas to all functions within the business.
  • Communicates with stakeholders globally to ensure alignment, resolve problems, and share best practices.
  • Develops presentations, status reports and measurement processes in support of the business.
  • Participates in any and all reasonable work activities as may be deemed suitable and assigned by management.
  • Conforms to, supports, and enforces all Company policies and procedures.

 Educational Requirements

  • Bachelors Degree in Biomedical, Materials Engineering, Chemical Engineering, Mechanical Engineering or relevant technical discipline.

Experience Requirements

  • Minimum 5-year experience in a manufacturing or production engineering environment.
  • Minimum of 3-year experience in medical devices with strong preference in wound dressings.
  • Demonstrated understanding of cGMP, Design Control and Validation practices.
  • Demonstrated experience in manufacturing transfer and project management.

Additional competencies/requirements:

  • Experience of product design a plus.
  • Flexibility around with working hours and travel.
  • Demonstrated competency in MS Access, Excel, Oracle/SAP/ERP & query development.
  • Ability to interpret engineering drawings/specifications/familiarity with inspection techniques.
  • Excellent interpersonal & communication skills.
  • Strong leadership, decision-making & problem solving skills.
  • Process Excellence qualification or training or knowledge of principles; competency in Six Sigma, practicing Green Belt a plus.

For a confidential discussion and more information on the role, please contact David Lennon on 09064 78104 and email your CV to david.lennon@collinsmcnicholas.ie

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