Process Development Engineer
Our client, a medical device company in Roscommon are currently looking to recruit a Process Development Engineer for their site.
Purpose of position:
- As a process development engineer you will work with cross functional teams to lead and participate in product and technology development projects.
- This will cover a broad range of clinical and technology fields, as required to meet the growing needs of our multinational based client companies.
- You will support development projects through a multi-phase program from concept to commercial launch.
- With clients or independently the ability to develop new concepts from initial design through design verification to market release.
- Leads the introduction of new technologies and optimizes existing technology.
- Designs and implements new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation.
- Conducts feasibility studies of the design to determine ability to function as intended.
- Maintains detailed documentation throughout all phases of research and development.
- Prepare effective project plans and manages project execution through development phases as appropriate.
- Conduct risk analysis for products under development.
- Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
- Execute validations of both product and technologies in conjunction with support functions.
- Any other duties as assigned.
- Development Engineers do not normally have any direct reports.
- However in certain circumstances, technicians, operators and/or students may be assigned to them and they are expected to effectively supervise these people under the guidance of their own or the assignee's supervisor.
- In his/her absence the Technical Manager or another Development Engineer (delegated by the Technical Manager) will deputise.
- Bachelor's degree in Mechanical, Plastics or Biomedical Engineering is desired.
- Minimum of 5 years of medical device design and development experience is desired.
- Good working knowledge of applied statistics desirable
- Familiarity with design for manufacturability is desired.
- Experience working with operations to develop strong manufacturing process instructions and operator training to ensure smooth product transition into the manufacturing environment is required.
- Ability to interact with client companies in a professional manner.
- Effective management of resources.
- Customer focus with excellent communication skills, written and oral.
- Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.
- Must have a good working knowledge of the medical device industry and of ISO13485, FDA QSIT and regulatory requirements. In particular s/he must have a detailed knowledge of MDD 93/42 EEC requirements and design control procedures.
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