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Senior Supply Chain Process Development Engineer - 2406198890W

Description

DEI:

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 a broad culture that values different perspectives and life experiences.

That is why we in Johnson & Johnson 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”!

CERENOVUS, part of the Johnson & Johnson Medical Devices Companies, is recruiting for a Senior Process Development Engineer located in Galway, Ireland. This is a permanent role.

This position supports the Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson. The CSS Group consists of four diverse businesses including Acclarent, Biosense Webster (BWI), Cerenovus, and Mentor.

CERENOVUS is a global 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. Our implants and instruments are used by interventional neuroradiologists, neurosurgeons and neurologists, to treat patients with conditions resulting from hemorrhagic and ischemic stroke. Our environment is entrepreneurial, learning-driven, and is as challenging as it is rewarding. We are one of the fastest growing businesses within Johnson & Johnson.

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 candidates’ 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 through 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 process 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.

Role: Senior Process Development Engineer

Reports to: Engineering Manager Technical Life Cycle

Key Responsibilities

• Work collaboratively as a core team member on a cross-functional project team to develop robust product design to ensure capable manufacturing processes.

• 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.

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Qualifications

Qualifications

• Mechanical or Biomedical Engineering degree or equivalent.

• A minimum of 6 years’ experience in medical device design and development

Experience

• Prior experience in medical device catheter process design and or manufacturing is highly desirable.

• Understanding of product lifecycle and validation requirements for a new product introduction.

• Experienced in developing validation strategies for equipment or processes, including preparation of protocols and reports. (OQ/PQ)

• Proficiency in structured problem-solving approaches is highly desirable. (e.g. Six Sigma, DMAIC)

• Project Management experience, developing project schedules and managing resources and execution, is desirable.

• 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.

Johnson & Johnson: Changing health for humanity

We’re building a world where complex diseases are prevented and cured, treatments are smarter and less invasive—and solutions are personal.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Equal Opportunity:

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location Europe/Middle East/Africa-Ireland-Galway-Galway

Organization Neuravi Ltd. (8191)

Travel Yes, 10 % of the Time

Job Function Process Engineering

Req ID: 2406198890W