Lead Research and Development Engineer

Cook Medical

Limerick, Ireland

Overview

This role will lead a team of engineers focused on research, development, and implementation of new medical device designs. This role will be responsible for technical leadership within the project team which could include signing off on deliverables and supporting the training and delegation of work responsibilities to other engineers on the team.

Reporting to: Manager, Research and Development/Senior Manager, Research and Development

Responsibilities

Lead project teams or provide technical leadership for medium to large scale Research and Development projects, collaborate to provide technical leadership across the department and/or multiple projects in a specific area or subject matter expertise.
- Lead a team in the development of chemical and physical analytical methods to support early stage product development.
- Drive capacity analysis within the Pharmaceutical Development Formulation team to ensure optimal and efficient use of resources and equipment.
Collaborate with internal and external team members in identification and evaluation of Critical Material Attributes (CMAs).
Drive improvement initiatives in area of expertise, which may include process ownership for department.
Where appropriate apply lean principles to the design and implementation of new processes.
Responsible for approval of work product or work for project teams.
Manage the activities of the project team and drive project tasks to ensure timely completion of project milestones and business metrics are achieved in collaboration with project manager (when one is assigned).
Work closely to build effective relationships with cross functional groups to achieve project and company goals.
As part of project/technical leadership, responsible for:
- Leading technical development of projects.
- Leading all key design decisions to ensure quality of design selection to meet customer needs.
- Retrospective project reviews to understand lessons learned.
Managing device evaluations and compliance with Quality, Regulatory and company policies and systems.
- Ensure all work undertaken within the team complies with current guidance and Industry best practice e.g. USP, Ph Eur (V), ICH.
May represent Cook in industry standards, working groups and present on Cooks behalf in industry conferences.
Act as a mentor to other personnel in the department.
Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

Qualifications

Bachelor’s degree in engineering (preferably in Polymer Science, Industrial Chemistry or Pharmaceuticals) or related field required and 7 years’ relevant experience OR
Master’s Degree and 5 years’ relevant experience OR
PhD and 4 years’ relevant experience.
Experience in Product Development projects within Medical Device - specifically combination product experience.
An excellent understanding of technologies (and challenges) associated with formulation and product development.
Competent in chemical and physical analytical methodology and testing procedures necessary for the development and approval of successful formulations.
Extensive proven knowledge of requirements associated with technical transfers to Manufacturing Operations.
Proven project/technical leadership.
Project management methodology and skills.
Proven experience working closely with project managers.
Knowledge of relevant ISO, EU, FDA medical device standards regulations is required.