Senior Process Development Engineer

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Senior NPI Process Development Engineer

Location: Galway

Duration: 12 months

Hours: 40

Johnson & Johnson Medtech Neurovascular, is recruiting for a Senior NPI Process Development Engineer located in Galway, Ireland. This is a 12-month contract role.

In this role, the candidate will be a core member of a cross functional teams responsible for developing and delivering complex acute ischemic stroke projects with significant technical challenges from initial concept through to commercialisation.

The candidate’s primary responsibility will be to work with the product development team, the suppliers of raw materials, and suppliers of manufactured assemblies, from individual components to final packaged, sterilised devices. The role will be involved throughout the entire product and process development cycle from initial prototyping through to process validation and commercialisation.

The key goals will be to ensure that optimal materials, suppliers, and manufacturing processes are selected and developed to deliver a high quality, capable, right- first-time product output at maximum yields and efficiencies to achieve/exceed manufacturing quality and cost targets.

Roles and Responsibilities

Work collaboratively on cross-functional project teams to develop robust product design to ensure capable manufacturing processes (Design for Manufacture).

Evaluate critical to quality requirements for components used to build complex acute ischemic stroke devices and translate these requirements into component specifications that ensure components are manufacturable and performance is maintained consistently.

Assess new and existing raw materials, component, and assembly suppliers for technical and manufacturing capabilities.

Drive process/product improvements (design for manufacture/design for assembly) related to sub-assembly 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 line and pilot lines.

Collaborate with suppliers and incoming inspection laboratories to develop, validate, and ensure appropriate inspection methods and controls are in place 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.

How to Succeed

Degree in Mechanical or Biomedical Engineering or equivalent.

At least 5-7 years of medical device medical process/device 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.

Experienced in developing validation strategies for equipment or processes, including preparation of FMEA’s 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 OEM is preferred.

Design tools and practices expertise including Design for Manufacture, Lean assembly, Solidworks, Prototyping and Test method development.

Strong understanding and proven experience using appropriate statistical tools throughout each project lifecycle stage.

Excellent communication / interpersonal skills required.

Ability to multi-task, working on multiple projects simultaneously.

High level of technical writing and reporting skills.

Strong work ethic, creative problem solving, capable of working on own initiative.

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

About Cerenovus
Cerenovus is part of Johnson & Johnson MedTech and an emerging leader in neurovascular care. Our commitment to changing the trajectory of stroke is inspired by our long heritage and dedication to helping physicians protect people from a lifetime of hardship. At Cerenovus we offer a broad portfolio of devices used in the endovascular treatment of hemorrhagic and ischemic stroke. Contribute to the next healthcare breakthrough with your next project at Cerenovus.

https://www.jnjmedtech.com/en-US/companies/cerenovus

Application process
We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available.

Diversity, Equity & Inclusion
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”

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Seniority level: Not Applicable

Employment type: Full-time

Job function: Engineering and Science

Industries: Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Manufacturing

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