Process Validation Engineer

Process Validation Engineer

Location: Galway

Duration: 12 months (opportunity for contract extension)

Working mode: Role starts off as on-site, opportunity for hybrid working later on

Hours: 40 hours per week

Pay rate range: Competitive hourly rate

An outstanding opportunity: This is a brand new role within Cerenovus that is ideal for candidates moving from process towards R&D. In this role, you will get a chance to work on new innovative concepts.

Imagine your next project as Process Validation Engineer. 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 haemorrhagic and ischaemic 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 responsible for developing and delivering complex acute ischaemic stroke projects with significant technical challenges. Responsible for various aspects of the projects, including process development, design development support through the product development lifecycle, implementation of new equipment/automation and new product introduction.

Emphasis will be on delivering projects on-time, within budget in a compliant and reliable manner. You will also be accountable for delivering projects which will require building project plans, aligning partners, managing the timeline, budget and driving team accountabilities to deliver the final project objectives. You will also work with functional partners to define/align on the business case and project scope to support project execution; following compliance defined through CERENOVUS' procedures.

roles and responsibilities

• Assess new and existing suppliers for technical and manufacturing capabilities.

• Identify critical to quality requirements for components used to build complex acute ischaemic stroke projects and translate these requirements into specifications and design outputs (test procedures)

• Work with suppliers to characterise and validate new and improved manufacturing processes.

• Work with suppliers and incoming inspection laboratories to develop, validate and improve inspection methods.

• 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.

• Identify process improvements (design for manufacture/design for assembly) related to sub-assembly or component usage or design.

• Implement changes under the Cerenovus change management system.

how to succeed

• Honours degree in Mechanical or Biomedical Engineering or equivalent.

• A minimum of 4 years’ experience in all stages of medical device design and development (including design with SolidWorks, prototyping, testing)

• Data review and statistical methods skills (Minitab)

• High level of technical writing and reporting skills.

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

Experience

• Experienced in executing validation of equipment or processes, including preparation of protocols and reports.

• Prior experience in medical devices or related industries is highly desirable.

• Exercise authority and judgment to resolve issues within defined limits to determine appropriate action.

• Green belt certification or experience in using a structured problem-solving approach is highly desirable.

• Experience in managing technical relationships with external suppliers and OEM is preferred.

• Supplier development skills preferred.

• Excellent communication / interpersonal skills required.

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

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

you are welcome here

Cerenovus is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

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. 

questions

If you would like some additional information about the role please contact:  sara.marsalo@randstadsourceright.co.uk (please note that we do not accept applications via email).

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”.