Job Title: Senior Technical Development Specialist
This is a fixed-term contract position based in Carrigtwohill, Cork, Ireland.
About the Role
We are seeking an experienced technical professional to join our team as a Senior Technical Development Specialist. In this role, you will be responsible for independently determining and developing approaches to various technical problems of moderate scope and complexity.
You will use the latest engineering techniques to reduce product time to market while adhering to regulatory requirements, project deadlines, and product costs. This involves building productive internal and external working relationships and providing guidance and training to other team members.
Main Responsibilities
* Provide engineering support for new product and process introductions, ensuring all activities are completed and documented according to procedures.
* Ensure quality of process and product as defined in operation and material specifications.
* Select components and equipment based on analysis of specifications, reliability, and regulatory requirements, working with quality engineers to develop component-specific testing and inspection protocols.
* Lead or support capital acquisition activity from specifying equipment, contract negotiation, installation, and validation.
* Analyse equipment to establish operating data, conduct experimental tests, and result analysis, leading and/or participating in process review meetings.
* Participate in PFMEA, Control Plan, SOP, and PPAP generation associated with product transfers and launches.
* Complete capability studies for in-process inspection and generate subsequent Inspection documentation.
* Conduct MSA studies for new products and new processes.
* Provide training for manufacturing team members.
* Ensure adherence to GMP and safety procedures.
* Review and approval of validation documentation.
Requirements
To be successful in this role, you will need:
* A Bachelor's degree in Mechanical Engineering or a related engineering discipline, with at least 4 years' experience.
* Proven track record of working in a team-based environment.
* Excellent interpersonal skills, able to express ideas and collaborate effectively with multidisciplinary teams.
* Innovative thinking, with the ability to envisage new and better ways of doing things.
* Experience in executing complex problem-solving techniques related to manufacturing/design technical issues.
* Good understanding of Design for Manufacturing (DFM), related statistical tools, and validation/verification techniques.
* Analytical skills, ability to plan, organise, and implement concurrent tasks.
* Good knowledge of manufacturing processes, materials, product, and process design.
* Ability to read and interpret complex engineering drawings and understand geometrical dimensioning and tolerancing.
* Experience in validation activities.