Principal Design Quality Engineer

Medtronic is working with new partners, in new ways to improve global healthcare. With the integration of Covidien as our Minimally Invasive Therapies Group, we can address the healthcare needs of more people around the world than ever.

Ensuring the quality of the design of life-saving medical devices. Does this work inspire you? The Principal Design Quality Engineer is a key technical leader for EndoVenous design projects and quality systems. In this role, you may lead or consult product development teams associated with design changes as well as New Product Development programs. You will focus on design related projects and deliverables required by the Product Development Process (PDP) and may serve as the Quality representative in Core teams. The Principal Design Quality Engineer will also provide technical mentorship and decision-making guidance to other product development, continuous improvement, and manufacturing teams. Principal Accountabilities: - Lead Quality actions as core team member on Sustaining Commercial Product Support and Product Design Change Development teams. - Manage risk throughout the development process through the creation and/or updates of risk management files and use of FMECA and/or other risk management tools. - Lead commercial risk management activities including; identification and analysis of complaint trends, evaluation of data trends versus the product risk files, and communication of conclusions and recommended actions to EndoVenous Leadership. - Lead cross functional problem solving and root cause analysis teams. - Develop strategies for and create master test plans for design verification, design validation and process validation activities that are sufficient to meet regulatory requirements and quality objectives - Specify quality characteristics and inspection plans for components, subassemblies, and finished devices.

Qualifications: - Bachelor’s Degree in Science or Engineering - MS in Science or Engineering desired - Strength in mechanical or electrical engineering - ASQ certification in Quality Engineering desirable - 10+ years of industry experience - 5+ years of experience in the Medical Device industry - 5+ years of experience in product & process development - Product development experience - Design Controls experience - Risk Management experience - Design verification and validation experience - Test Method development and validation experience - Knowledge of statistics - ANOVA, DOE experience preferred - Understanding of Confidence and Tolerance Limits - SPC - Process Development, Characterization, and Validation experience - Process Improvement Tools experience - Lean Manufacturing experience - Six Sigma preferred - Ability to deliver on multiple projects simultaneously - Ability for reasoning and logical deduction - Ability to make decisions in a fast pace environment - Ability to solve very complex problems that require creativity - Excellent prioritization and verbal/written skills - Proficient at influencing subordinates, peers, and senior management - Proven ability in coaching technical professionals to achieve maximum performance - Self-directed and committed to a team approach