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
Join our Coronary and Renal Denervation Design Assurance Team, where our purpose is to ensure highest quality standards during development of new products – from early phase through to verification. We do this throughout product development by translating design requirements and the voice of the customer into innovative design solutions, collaborating with dynamic cross-functional teams to deliver high-quality products that satisfy patient and customer needs.
Come for a job, stay for a career!
A Day in The Life Of:
You will serve as extended team member on a PDP Project representing the Design Assurance function and will report dotted line to the quality lead on the project.
Lead design assurance activities for new product development and sustaining engineering projects.
Develop and implement risk management processes according to ISO 14971 standards. Conduct risk assessments, FMEA, and ensure risk controls are adequately implemented.
Oversee design verification and validation activities, including test planning, execution, and documentation to ensure compliance with regulatory standards.
Ensure adherence to quality management systems in compliance with ISO 13485 and other relevant standards.
Collaborate with regulatory affairs to ensure that products meet regulatory requirements and provide support during regulatory submissions and audits.
Drive continuous improvement initiatives within the design assurance process to enhance efficiency, effectiveness, and compliance.
Provide training, guidance, and mentorship to junior engineers and other team members on design assurance practices and principles.
Ensure all design assurance documentation is complete, accurate, and maintained in accordance with company policies and regulatory requirements.
Key Skills & Experience
We are looking for a person qualified to minimum Bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering or Science), with 7+ years of experience in Engineering, Quality.
Experience in the management of complex data sets and statistical data analysis.
Exhibits strong problem-solving skills with a creative and innovative mindset.
Capable of generating original ideas and implementing solutions to enhance organisational goals.
You are a dynamic team player, can work effectively and proactively on cross-functional teams with excellent technical writing skills.
Effective communication skills – distill complex issues into concise and clear messages.
You are an experienced professional in engineering development with extensive engineering knowledge and skills in some or all of the following: test method development, design for six sigma principles, pre-clinical evaluations, system requirements development, design control, application of ISO standards for medical devices, capital equipment, basic electrical engineering principles.
Collaborates and creates alignment, thinks critically and makes sound decisions.
Practical knowledge of project management.
Physical Job Requirements
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
