Senior Process Engineer

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Overview

Johnson & Johnson Medtech Neurovascular is recruiting for a Senior NPI Process Development Engineer located in Galway, Ireland. This is a 12-month contract role. The candidate will be a core member of cross-functional teams responsible for developing and delivering complex acute ischemic stroke projects from concept through to commercialisation.

The primary responsibility is to work with the product development team and suppliers of raw materials and manufactured assemblies, from components to final packaged, sterilised devices. The role covers the entire product and process development cycle from prototyping through process validation to commercialisation. 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.

Responsibilities

• Work collaboratively on cross-functional project teams to develop robust product designs and capable manufacturing processes (Design for Manufacture).
• 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.
• Assess new and existing raw materials, components, and assembly suppliers for technical and manufacturing capabilities.
• Drive process/product improvements (design for manufacture/ design for assembly) for sub-assemblies or component usage or design.
• Manage prototype builds to support characterization and develop assessment strategies.
• Develop strategies to characterize and validate new and improved manufacturing processes and components on external supplier manufacturing lines and pilot lines.
• Collaborate with suppliers and incoming inspection laboratories to develop and validate inspection methods and controls for components and finished devices.
• Identify project risks and develop mitigation strategies to ensure supply, quality and timelines are met.
• Monitor supplier performance and provide technical support to resolve issues.
• Implement changes under the Cerenovus change management system.
• Other duties as assigned or required.

Required Experience & Education

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

This role offers a very competitive hourly rate. This contract will run for 12 months.

What it's like to work at J&J Medtech Neurovascular Galway

• Culturally we prioritize Our Credo stakeholders, quality, compliance, and ethics to contribute to Our Purpose.
• 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.
• Commitment to a positive work environment that respects diversity, supports wellbeing, and embraces innovation; emphasis on inclusion through employee resource groups and diverse candidate pipelines.

Application process

• We aim to process the first round of applications within the next 2 working days.
• Pay rate depends on compensation method; PAYE, LTD & Umbrella options are available.

Diversity, Equity & Inclusion

For more than 130 years, DEI has been part of Johnson & Johnson's culture and credo. Our commitment is to respect the dignity and diversity of all people and to create an inclusive environment where everyone belongs.

Seniority level

• Mid-Senior level

Employment type

• Contract

Job function

• Manufacturing, Research, and Product Management

Industries

• Medical Equipment Manufacturing
• Pharmaceutical Manufacturing

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