Senior NPD Process Engineer (Validation)

GxP Recruitment; Clonmel; On-site; EUR 72,000 - 93,000; Full time

Job summary

GxP Recruitment is seeking an experienced Process Development Engineer for medical device manufacturing in Clonmel, Ireland. Under minimum supervision, you will collaborate with R&D and Manufacturing to develop robust, cost‑effective and safe processes and to support transfer of new products into commercial production.

You will initiate technical activities for next generation programs, design and evaluate mechanical/electro‑mechanical processes, and apply DMAIC tools to improve equipment

Qualifications

• Initiates and completes technical activities leading to new or improved products or processes for next generation programs and to meet strategic goals and objectives of the company.
• Researches, develops, designs, and evaluates mechanical and electro-mechanical processes and/or equipment.
• Analyses and solves problems from basic engineering principles through to a wide range of complex and advanced problems which require novel approaches or a breakthrough in technology.
• Demonstrates good working knowledge of DMAIC tools and applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance.
• Introduces new processes, equipment and materials including installation, calibration, EHS assessment, debug, and all associated process and quality system documentation requirements.
• Demonstrates advanced technical expertise on process/product technologies to support design, optimisation, validation and troubleshooting of those technologies, equipment or materials.
• Demonstrates good working knowledge and application of IQ, OQ, PQ validation techniques, PFMEA’s, and regulatory requirements and applies this knowledge in the support of efficient and timely validation of equipment and processes.

Responsibilities

• Initiates and completes technical activities leading to new or improved products or process for next generation programs and to meet strategic goals and objectives of the company.
• Prepares reports, publishes, and makes presentations to communicate findings.
• Researches, develops, designs, and evaluates mechanical and electro-mechanical processes and/or equipment.
• Analyses and solves problems from basic engineering principles through to a wide range of complex and advanced problems which require novel and new innovative approaches or a breakthrough in technology.

Education

Level 8 degree or equivalent

Master’s qualification in Engineering or Science discipline

Job description

Under minimum supervision or direction, works closely with R&D and Manufacturing in the development of robust, capable, cost effective & safe manufacturing processes to support transfer of new products & processes into commercial production.

Key Responsibilities:

• Initiates and completes technical activities leading to new or improved products or process, for next generation programs and to meet strategic goals and objectives of the company. Prepares reports, publishes, and makes presentations to communicate findings.
• Researches, develops, designs, and evaluates mechanical and electro-mechanical processes and/or equipment.
• Analyses and solves problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a breakthrough in technology.
• Demonstrates good working knowledge of DMAIC tools and applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance.
• Introduces new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.
• Demonstrates advanced technical expertise on process/product technologies to support design, optimisation, validation and troubleshooting of those technologies, equipment or materials.
• Demonstrates good working knowledge and application of Processes and equipment validation techniques (IQ, OQ, PQ), PFMEA’s, and associated regulatory requirements and applies this knowledge in the support of efficient & timely validation of equipment and processes.

Qualifications

• Level 8 degree or equivalent, master’s qualification in Engineering or Science discipline a distinct advantage
• A minimum of 6-8 years experience in a similar role in the medical device industry.
• Experience in additive manufacturing and post processing is a bonus.
• Experience in process development, characterization, and validation.