We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful class leading innovations.
This position offers the exciting opportunity to join the successful Aortic, Peripheral and Vascular (APV) Business Unit as a Principal Quality Engineer.
This position encompasses QA and technical support of the franchise value stream products, leading creative improvement initiatives, project management, coaching and global cross functional collaboration.
POSITION RESPONSIBILITIES:
Manages all aspects of quality product management for commercially released products. This includes but is not limited to monitoring product field performance, addressing identified trends, technical and risk management-based product analysis, leading consequent clinical impact to recommend any necessary corrective field actions.
Leads cross-functional teams to investigate field reported quality events. Presents overall field performance trends, clinical outcomes and device failures to the rest of the organization as input to improve product design or manufacturing processes.
Leads the initiation and executions of system level improvement plans across a variety of areas, using Lean principles, to increase efficiency, reduce cost and streamline operations. Leads or participates in other sustaining engineering projects or initiatives.
Supports Regulatory Affairs by providing quality input for notified body submissions or follow up queries.
Demonstrates excellent technical writing when authoring assigned Product Risk Assessment, Health Hazard Analyses, Post-Market Surveillance Reports. Facilitates Design FMEA and Risk Management File updates on assigned product lines.
Leads or owns in corrective/preventive action teams to resolve systemic issues. Partners with cross-functional peers to resolve product performance issues (NCMRs, CAPAs, deviations, manufacturing process problems etc.) to assess impact on device quality and product availability.
Partners with multiple manufacturing sites and external suppliers to review and assess any design or process changes that may impact the product specifications or overall performance. Helps create qualification strategies to implement complex changes.
Mentors peers in the organization and helps facilitate technical and professional development of others.
Must Have: Minimum Requirements
Bachelor's Degree in Engineering, Science, or other Technical Discipline
7+ years (with Bachelor's) or 5+ years (with Master's) of industry experience in Engineering, Science, or other technical discipline
Nice to Have
Experience in a highly-regulated industry, preferably implantable medical devices
Knowledge and experience in application of statistics and lean sigma principles
Knowledge of cardiac anatomy, physiology, and primary disease states
Working knowledge of 21 CFR Part 820 (Quality System Regulation), ISO 13485, EU Medical Device Directive and relevant international standards.
Experience in the application of Risk Management (ISO 14971) and hazard analysis and risk analysis techniques (e.g., PHA, DFMEA)
Demonstrated ability to work in a matrix organization and positively influence strategy and outcomes
Ability to deliver on multiple projects simultaneously, and balance between long- and short-term priorities
Demonstrated critical thinking skills with focus on improved system performance outcomes and positive business impact
Excellent problem-solving skills, including demonstrated application of structured problem-solving methods and tools
Strong written and oral communication skills (timely, clear, concise, accurate, conclusive, influential, targeted to audience)
Strong collaboration and influence skills (build relationships, leverage others, align and work towards shared outcome-based goals, understand others' needs, negotiate for win-win, own the whole)
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)
