Video for this job

Collins McNicholas

Job Description


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 090 64 78104 or email

Firstname (required)

Surname (required)

Your Email (required)

Your mobile (required)

Upload CV (required)


In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Why Inma Aguilera chose Galway for her career

Inma Aguilera, Manufacturing Process Development Engineer, Creganna Medical, Galway Beautiful scenery, a fifteen-minute commute and the opportunity to grow her career. Why Inma Aguilera is loving life in Galway! The West of Ireland is a great place for engineers to further their careers because there are so many large companies where you can grow and progress your […]
Read More