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Job Description
Process Development Engineer – Medical Devices
Location: Cork, Ireland
Join a dynamic and innovative team in Cork, Ireland, as a Process Development Engineer supporting the introduction of advanced upgrades to an existing medical device line. This role offers the opportunity to deliver cutting-edge and practical manufacturing solutions while playing a crucial part in bringing new products to market.
Key Responsibilities
- R&D Collaboration: Act as the vital link between the Research & Development team and the Cork site to technically understand requirements and develop efficient manufacturing processes.
- New Product Development: Support the R&D team during the product design phase, ensuring manufacturability and process improvements are integrated early on.
- Risk Mitigation & Process Optimisation: Manage the process introduction with a focus on reducing product and process risks, improving yields, and enhancing overall efficiency.
- Vendor Management: Collaborate with vendors to develop and validate automated systems for high-quality production processes.
- Equipment Integration: Oversee the successful introduction of newly designed equipment into the production environment, ensuring smooth operation and adherence to quality standards.
- Process Validation Leadership: Lead the validation process, ensuring all stakeholders meet their requirements and that every department plays their part efficiently and on time.
- Project Management: Plan and execute process introductions, keeping budget and timelines in mind while ensuring product quality is never compromised.
- Innovative Problem Solving: Address process, safety, product, timeline, and budget risks with creative, efficient solutions.
- Technology Integration: Identify and implement innovative technologies to support chemical and manufacturing processes as required.
Qualifications
- Education: Bachelor's degree or higher in Mechanical Engineering or a related field.
- Experience: Minimum of 5 years' proven experience in medical devices, particularly in process introduction and validation.
- Expertise:
- Strong background in validation, risk management, change management, and statistical analysis.
- Knowledge of ISO requirements, GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes.
- Skills:
- Ability to work in cross-functional teams, supporting new product development (NPD) and design transfer to manufacturing.
- Strong project management skills with a focus on budget, timelines, and process optimisation.
This is a unique opportunity for a talented Process Development Engineer to join a forward-thinking company at the cutting edge of medical device technology. Apply today to be part of an exciting team where your contributions will have a real impact on global healthcare innovation.
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