Process Development Engineer

CREGG; Burlington; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading Medical and Pharmaceutical Device company is seeking a Process Development Engineer to optimize manufacturing processes. You will work closely with R&D to develop robust procedures and validate new designs. The ideal candidate has a Level 8 degree in engineering and 2+ years of experience in medical devices. This role involves significant engagement with process and equipment validation.

Qualifications

• 2+ years relevant experience in medical devices.
• Experience in process validation and characterizing new processes.
• Excellent leadership abilities to manage cross-functional teams.

Responsibilities

• Develop robust high-yielding processes for medical devices.
• Optimize performance of process equipment for manufacturing.
• Liaise with R&D for new designs and transfer validated processes.

Skills

Interpersonal skills

Communication skills

Analytical skills

Problem solving skills

Education

Level 8 degree in relevant Engineering or Science discipline

Tools

Injection Moulding

DMAIC

Job description

CREGG Recruitment are hiring for a Process Development Engineer to join a leading Medical and Pharmaceutical Device company in Galway.

For more information contact Mark

[e-mail] or 0861901346

Purpose Statement

To work closely with R&D Engineering and Manufacturing to develop robust, capable manufacturing processes for the production of medical devices. Multiple projects supporting large automation equipment being used to assemble and test medical devices. Seeing process and equipment builds from concept through to implementation.

Key Responsibilities

• Development of robust (high capability) high yielding processes.
• Optimization of process equipment and technology performance to enable transfer of efficient and repeatable processes to manufacturing.
• Work closely with R&D engineering to develop new medical device designs and transfer validated designs to manufacturing.
• Vendor engagement for equipment design and builds. Supporting these from concept to implementation onsite.
• Equipment design and improvements to existing to update processes to facilitate NPI’s.
• Documentation, preliminary and manufacturing.
• Writing and carrying out validations / qualifications.
• Continued quality improvement.
• Liaise with other relevant functions with regard to ongoing development of current processes and future development needs.
• Develop and maintain expertise in Cork site.
• Will be responsible for commissioning any new microcatheter manufacturing technology, ramping up production, undertaking validations, continuous process improvement and identifying potential development opportunities for medical device technology.
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.

• Qualifications & Experience
• Level 8 degree in relevant Engineering or Science discipline (Manufacturing, Mechanical, Electronic, Production etc).
• 2+ years relevant experience in medical devices
• Excellent interpersonal and communication skills with good leadership abilities.
• Excellent analytical and problem solving skills.
• Experience in at least 1 of the below is required.
• Injection Moulding
• Process development and process characterization
• Process problem solving
• Process validation
• DMAIC
• Equipment validation
• New product introductions