Process Development Specialist

Process Development Engineer

We are seeking a skilled Process Development Engineer to join our team in Galway, Ireland. The successful candidate will play a crucial role in developing and delivering complex acute ischemic stroke projects from concept through to commercialization.

The primary responsibility of this position is to work with the product development team and suppliers of raw materials and manufactured assemblies, from components to final packaged, sterilized devices. The engineer will cover the entire product and process development cycle from prototyping through process validation to commercialization. The goal is to ensure optimal materials, suppliers, and manufacturing processes to deliver a high-quality, right-first-time product at maximum yields and efficiencies to meet manufacturing quality and cost targets.

This is a 12-month contract role offering a competitive hourly rate. The successful candidate will be a core member of cross-functional teams responsible for developing and delivering complex acute ischemic stroke projects.

1. Work collaboratively on cross-functional project teams to develop robust product designs and capable manufacturing processes (Design for Manufacture).
2. Evaluate critical-to-quality requirements for components used in complex acute ischemic stroke devices and translate these into component specifications that ensure manufacturability and consistent performance.
3. Assess new and existing raw materials, components, and assembly suppliers for technical and manufacturing capabilities.
4. Drive process/product improvements (design for manufacture/design for assembly) for sub-assemblies or component usage or design.
5. Manage prototype builds to support characterization and develop assessment strategies.
6. Develop strategies to characterize and validate new and improved manufacturing processes and components on external supplier manufacturing lines and pilot lines.
7. Collaborate with suppliers and incoming inspection laboratories to develop and validate inspection methods and controls for components and finished devices.
8. Identify project risks and develop mitigation strategies to ensure supply, quality, and timelines are met.
9. Monitor supplier performance and provide technical support to resolve issues.
10. Implement changes under the Cerenovus change management system.
11. Other duties as assigned or required.

1. Degree in Mechanical or Biomedical Engineering or equivalent.
2. At least 5-7 years of medical device process/design and development experience in a regulated environment.
3. Prior experience in medical device catheter process design and/or manufacturing is highly desirable.
4. Understanding of product lifecycle and validation requirements for new product introduction.
5. Experience in developing validation strategies for equipment or processes, including preparation of FMEAs, protocols, and reports.
6. Proficiency in structured problem-solving approaches (e.g. Six Sigma, DMAIC).
7. Project management experience, developing project schedules and managing resources and execution.
8. Experience in managing technical relationships with external suppliers and OEMs is preferred.
9. Design tools and practices including Design for Manufacture, Lean assembly, SolidWorks, Prototyping, and Test method development.
10. Strong understanding and experience using appropriate statistical tools throughout the project lifecycle.
11. Excellent communication and interpersonal skills; ability to multi-task and manage multiple projects.
12. High level of technical writing and reporting skills; strong work ethic and creative problem-solving.

This role offers a very competitive hourly rate. We prioritize Our Credo stakeholders, quality, compliance, and ethics to contribute to Our Purpose.

• Culturally we emphasize diversity, supports wellbeing, and embraces innovation; emphasis on inclusion through employee resource groups and diverse candidate pipelines.
• Engagement in Neuro Thromboembolic Initiative (NTI) to advance stroke treatment through interdisciplinary collaboration and research.
• Strong new product pipeline and status as a fast-growing medical device company within J&J.