Engineer - Research & Development
St. Jude Medical - Plymouth, MN

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Position Summary:
Support product development teams by providing appropriate anatomical data and/or models to evaluate device performance. The position requires a strong understanding of product performance requirements and the test methodology used to insure requirements are met. This person will be involved up-front data gathering (physician feedback, CTs, MRIs, etc), definition of model needs, creation of the model itself, and associated training requirements.

Essential Functions:
  • Gather anatomical information through literature research, face-to-face interaction, and analyzing of clinical data such as CT scans, MRI data, etc.
  • Generate technical reports supporting the clinical appropriateness of models
  • Design, execute, analyze (using appropriate statistical methods), and summarize results of characterization testing
  • Work with design engineers to identify key product characteristics to be evaluated
  • Identify and establish relationships with vendors and other outside suppliers for testing and/or fixture design
  • Conceptualize new devices using material knowledge and innovative mechanical design
  • Work with outside consultants, vendors, and the medical community
  • Support animal and bench testing and clinical evaluations
  • Support design reviews and physician visits
  • Maintains knowledge of the developing clinical environment (i.e. current treatment methods, evolving clinical needs etc.)
  • Ensure compliance with procedural and documentation requirements of SJM, FDA and ISO design controls
  • Determine when existing models/equipment can be leveraged and when novel ideas are required
  • Demonstrates the ability to analyze a problem, determine and execute a plan of action, and report on results
  • Demonstrated creativity and "hands on" prototyping skills
  • Demonstrated ability to adapt to the changing needs of a project
  • Demonstrated ability to meet deadlines
  • Demonstrated ability to influence team members
  • Ability to work independently and take initiative
  • Works well in a team environment
  • Shows initiative in gaining in-depth experience in areas of technology relevant to testing of company products
  • Ability to make important decisions within area of expertise
  • Excellent written and verbal communication, record keeping, and problem solving skills
  • Bachelor’s degree in engineering or related scientific discipline
  • 8+ years of medical device experience
  • Experience with both 510(k) and PMA medical device products, preferably cardiovascular
  • Knowledge of anatomy and physiology
  • Proficient in the use of lab and test system equipment and statistical theory required for data analysis
  • Development of a file vaulting system preferred
  • Working knowledge of Solidworks preferred
  • Working knowledge of 3mensio or MIMICS imaging analysis software preferred

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