R&D Process Validation Engineer Ii

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all.
You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Medtronic
At Medtronic, we value what makes you unique.
Be part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
Our Purpose
At our R&D Department, in Medtronic Athlone we focus on providing stable, flexible and cost effective solutions to enhance our processes and systems that produce the highest quality products through the deployment of innovative engineering projects and solutions.
R&D Process Validation Engineers are directly involved in understanding and providing compliance solutions and documentation throughout the project lifecycle, designed to continuously improve our manufacturing processes, systems, quality and regulatory compliance to the highest standards.
Come for a job, stay for a career
A Day in The Life Of:
Responsibilities may include the following and other duties may be assigned.
As part of our EU MDR Compliance project, prepare the process validation protocols and work with the relevant Engineers in terms of execution of the validation and documentation of the resulting test report.
Work with supervisor and Validation Team in terms of establishing gaps in the Project Validation Master Plans, creating schedules/timelines to address same and regularly reviewing the Master Validation Plan for adequacy
Collaborates with Manufacturing and Mfg.
Quality functions to ensure quality standards are in place.
Risk Management – As part of a team, support the completion of Risk Management to include the use of tools such as Failure Modes Effect Analysis (FMEA), Fault Tree Analysis etc.
to all product groups.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Suggest relevant changes to procedures and update to standard operating procedures as necessary.
Liaise with cross functional team members, developing strong partnering relationships with these to establish inspection methods which ensure effective product acceptance actives.
Key Skills & Experience
Level 8 Degree in a relevant Quality/Engineering/Science related discipline.
Preferably with 2 – 3 years relevant experience in a medical devices or similar regulated environment.
Medical Device Process Validation experience a distinct advantage.
Knowledge of plastic processing techniques such as Extrusion, Injection Moulding, Blow Moulding, Assembly, etc.
Knowledgeable in Quality Systems, validation standards, policies, procedures and methodologies.
Knowledge, understanding and implementation of GAMP5 is an advantage.
Experienced with practical working knowledge of statistical data analysis and quality improvement tools and techniques.
Dynamic team player and leader, with the ability to work effectively and proactively on cross-functional teams
Ability to be self-directed and to effectively interface with various levels and functions within the organization
Focused on patient and customer and set high standards, instill operational excellence, and drive accountability.
Excellent written, documentation, and oral communication skills and are fluent in English, both written and spoken.
Excellent organizational skills and have the ability to prioritize and work effectively on multiple projects.
Good communication skills.
Physical Job Requirements
Medtronic offer a competitive salary and flexible Benefits Package
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values.
We recognize their contributions.
They share in the success they help to create.
We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people.
From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves.
We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here #J-18808-Ljbffr