Senior Design Assurance Engineer - Pre-Market Quality
Bachelor’s Degree in Engineering or Science with 4+ years of work experience in Quality and/or Engineering OR Master’s Degree in Engineering or Science with 2+ years of work experience in Quality and/or Engineering.
Nice to Have (Preferred Qualifications)
• Bachelor’s Degree in Biomedical, Mechanical, Chemical or Electrical preferred.
• Master’s Degree in Engineering, Quality, Regulatory, or related.
• Experience working in a regulated industry (e.g., FDA-regulated).
• ASQ Certification in Quality or Reliability.
• Strong understanding and hands on experience with the FDA production and process controls (P&PC), experience in planning of process validation / test method validation activities.
• Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 62304, IEC 60601-1 and MDD.
• Understanding of the interdependencies of program work products and guide the teams in execution strategy and reviewing the program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).
• Experience with planning and executing design verification testing, test method development and test method validation (hands on execution experience preferred).
• Working knowledge of hardware development for medical devices.
• 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 physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
