Senior R&D Engineer

3 weeks ago

Lafayette, Louisiana, United States Medtronic Full time
About the Role

We are seeking a highly skilled Senior R&D Engineer to join our Electrosurgery group at Medtronic. As a key member of our team, you will be responsible for driving design integrity across multiple ES product lines to attain business goals consistent with cost, high quality, reliability, and delivery requirements.

Key Responsibilities
  • Ensure design integrity on ES products through material, process, and regulatory changes to maintain product safety and quality.
  • Collaborate with cross-functional teams to define project requirements, objectives, and timelines.
  • Support and collaborate with Operations, Contract Manufacturers, and Supply Chain partners.
  • Establish and maintain processes and documentation to support regulatory submissions, including design history files (DHF) and risk management files (RMF).
  • Evaluate field returns and perform root cause analysis to assess the patient/user risk associated with the post-market life-cycle phase.
  • Provide in-depth analysis and formulate recommendations on product improvements.
  • Assess applicable product requirements for Engineering Change (EC) processes.
  • Act as a mentor to colleagues and direct the work of lower-level professionals.
  • Work independently under limited supervision to determine and develop solutions to issues.
  • Participate in meeting departmental goals and objectives.
Requirements
  • Bachelor's degree in engineering or another technical field of study with 4+ years of experience in engineering.
  • OR an advanced degree in engineering or another technical field of study with 2+ years of experience in engineering.
Preferred Qualifications
  • Bachelor's degree in Mechanical Engineering with 4+ years of medical device engineering experience.
  • Experience with medical device design sustaining.
  • Strong understanding of design, development, and sustaining requirements of medical devices.
  • Knowledge of medical device regulations and various technical standards.
  • Understanding of common manufacturing processes (i.e. Injection Molding, Metal Forming, Machining, Heat Treating etc.).
  • Strong project management skills and experience.
  • Knowledge of process validation, including IQ, OQ, & PQ.
  • High degree of initiative and self-motivation.
  • Knowledgeable in engineering change control processes and product life cycles.
  • Trained/Certified in Lean and/or 6 Sigma and statistical analysis tools.
  • Ability to compile and analyze technical data using Minitab, Excel, R, and/or Matlab.
  • Proficiency with 3D modeling software such as Creo, SolidWorks, AutoCad, and Windchill PLM.
  • Proven problem-solving abilities.
  • Strong communication and inter-personal skills.
  • Hands-on mentality.
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.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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