POSITION OVERVIEW
The role will be responsible for supporting the design and development of innovative packaging solutions and Contract Pack introductions at Steripack Ireland. Primary responsibilities will include the development of test methods, supporting process validation activities, execution of material trials, and the manufacture of prototype samples for the sales team.
KEY RESPONSIBILITIES
Develop conceptualization and design of new product concepts.
Deliver engineering documents, raw material specifications, and finished good specifications; conduct engineering reviews and may be involved with implementation oversight including equipment, material validations and processing protocol development.
Develop specifications for products and processes, including URS, FAT, SAT, IQ, OQ, PQ, Risk Management and documentation required for validation and verification of products and processes.
Develop test methods and protocols for execution.
Build the process capability to meet the quality standards required for the design and manufacture of products.
Provide training to technical personnel.
Analyse, design, set‑up, produce and develop design and manufacturing solutions to engineering challenges associated with manufacturing technologies.
Provide customer support, including technical support and direct support to accelerate the closure of sales proposals.
QUALIFICATIONS, KNOWLEDGE, SKILLS, EXPERIENCE
Bachelor’s or advanced degree in Engineering.
2 to 5 years’ experience in product development within medical devices.
Experience with continuous improvement efforts to improve efficiencies and costs.
A demonstrated ability to work independently or as part of a team to complete projects within required timeframes.
Knowledge and experience in statistical analysis and statistical process control.
Previous experience in medical device or other regulated industries.
Expertise in developing projects with ISO16890, EN779, EN14683, EN149.
Knowledge and aptitude of IQ, OQ, PQ validations/protocols for medical production lines.
PERSON SPECIFICATION AND CORE COMPETENCIES
A demonstrated ability to work independently or as part of a team to complete projects within required timeframes.
Uses curiosity to investigate and explore technical issues.
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