Senior Reliability Engineer
MedtronicAbout the role
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
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
If you’re looking for a challenging and rewarding career that makes a real difference, join us. Help bring the next generation of life-changing medical technology to patients worldwide.
Interventional Cardiology Therapies (ICT) are a key part of the Medtronic portfolio, focused on addressing unmet needs in the growing areas of complex Percutaneous Coronary Intervention (PCI), Renal Denervation (RDN), and Structural Heart therapies.
The Design Assurance team is committed to maintaining the highest quality standards throughout new product development, from early concept through verification. By translating design requirements and customer needs into innovative solutions, the team partners with cross-functional colleagues to deliver high-quality products that meet patient and customer expectations.
Come for a job, stay for a career!
A Day in The Life Of:
- Serve as the Design Assurance representative on PDP projects, with dotted-line reporting to the Quality Core Team Member.
- Collaborate effectively across a matrixed team to align priorities, solve problems, and achieve project goals.
- Work independently to plan and schedule your own activities, which are necessary to meet timelines.
- Communicate progress to project leadership regularly, presenting complex issues in a clear, concise, and actionable way.
- Perform reliability analyses across requirements, architecture, interfaces, and design using tools such as FTA, failure trending, and reliability forecasting to assess product and process robustness.
- Lead risk management activities to ensure compliance with FDA, ISO 14971:2019, and ISO 13485:2016 requirements.
- Lead and complete complex test method validation activities for system and capital equipment test methods, including operator training, validation study design and sample size definition, data analysis (including crossed gage R&R, ANOVA, and probability of misclassification), reduction of variation sources, and report writing.
- Drive continuous improvement in Design Assurance to boost efficiency, effectiveness, and compliance.
Key Skills & Experience
- Demonstrates advanced expertise in the field, with broad and in-depth knowledge typically gained through a combination of higher education and relevant experience.
- This expertise is typically developed through advanced academic qualifications and professional experience.
- Holds a minimum Level 8 degree in Engineering or a related discipline, with at least 4 years of relevant experience.
- Alternatively, holds an advanced degree with a minimum of 2 years of relevant experience.
- Practical project management knowledge is desirable.
- Experience in a highly regulated environment, ideally within the medical device industry.
- Proven ability to resolve complex issues through collaboration with cross-functional teams.
- Demonstrated ability to work effectively in a matrix organization and navigate complex business systems, regulations, standards, and performance requirements.
- Knowledge of reliability tools and practices that support requirements, design, integration, verification, and validation.
- Strong critical thinking skills, with a focus on improving system performance and delivering positive business outcomes.
- Excellent communication skills and the ability to influence others are essential for success in this role.
- Experience managing complex data sets and conducting statistical analysis.
Medtronic offer a competitive salary and flexible Benefits Package
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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.
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