Principal Mechanical Design Engineer

21 hours ago

Miami FL USA, United States Medtronic Full time
About the Role

We are seeking a highly skilled Principal Mechanical Design Engineer to join our Mechanical Circulatory Support (MCS) Operating Unit at Medtronic. As a key member of our team, you will be responsible for providing technical expertise and leadership in the design and development of our HeartWare HVAD System.

Key Responsibilities
  • Develop new mechanical and electromechanical systems, subsystems, and components for our HeartWare HVAD System.
  • Lead design activities on assigned projects, collaborating with or supervising other department engineers, and interfacing with customers to exchange technical information.
  • Provide technical expertise to other departments, including Manufacturing, Marketing, Regulatory, Quality Assurance, and Program Management.
  • Support development testing and failure investigation of legacy and new products.
  • Work with Manufacturing Process Engineering and Quality Assurance Engineering to lead design engineering teams through design changes required to maintain product supply.
  • Design and develop project documentation within the scope of Design Controls for the design and development of heart assist pump projects.
  • Develop project schedules and identify resource requirements to meet continuity of supply objectives.
  • Work closely with Regulatory Affairs for submissions to appropriate worldwide regulatory agencies.
  • Mentor and supervise less-experienced engineers.
Requirements
  • Bachelor's degree in mechanical or biomedical engineering, science, or related technical discipline.
  • Minimum of 7 years of relevant experience in product development of medical devices or advanced degree in mechanical or biomedical engineering, science, or technical field with 5+ years of relevant work experience.
  • Advanced understanding of FDA design controls, quality system regulations, failure investigation process, and methodologies.
  • Advanced Subject-Matter-Expert (SME) knowledge of the HeartWare HVAD System.
  • PC application skills: solid modeling (SolidWorks), MS Project, EXCEL, Word, Minitab, Agile PLM.
  • Advanced understanding and application of GD&T (Geometric Dimensioning and Tolerancing).
  • Advanced understanding of Risk Management Process.
  • Advanced understanding of Design-for-Manufacturability (DFM), Design-for-Assembly (DFA), and Medtronic Design for Reliability and Manufacturability (DRM).
  • Project management and organizational skills.
  • Strong written and oral communication skills.
About Medtronic

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.

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