Principal Design Assurance Engineer - Pre-Market Quality (On-site/hybrid only)
Must Have: Minimum Requirements
- Bachelor’s Degree in Engineering, Science or technical field with 7+ years of work experience in Quality and/or Engineering OR Advanced Degree in Engineering, Science or technical field with 5+ years of work experience in Quality and/or Engineering.
Nice to Have (Preferred Qualifications)
- Experience working in a regulated industry (e.g., FDA-regulated)
- Master’s Degree in Engineering, Quality, Regulatory, or related.
- Working knowledge of electromechanical medical devices with embedded firmware and systems with mobile and cloud applications
- Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1, MDD & EU MDR.
- Project experience in hardware testing practices, methodologies and techniques, particularly in testing medical devices is a plus
- Ability to author technical reports, business correspondence and standard operating procedures.
- Ability to apply knowledge and work with development and supply vendors to ensure compliance to Medtronic requirements.
- Strong verbal and written English communication skills with an ability to effectively communicate at multiple hierarchal levels in the organization.
- Ability to multi-tasks, prioritize, meets/exceed deadlines and hold themselves, and others accountable.
- Self-Starter with a sharp focus on quality and customer experience.
About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
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.
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
