R-D Engineer II

1 month ago


Santa Rosa, United States Planet Pharma Full time

Top Needs:

  1. Candidate with some level of industry experience in Bio-Tech or Medical Devices industry
  2. Good problem solving skills with experience in performing root-cause analysis
  3. Hands-on experience with test method development, fixture design and mechanical component design


A Day in the Life

  • Design, develop and optimize transcatheter heart valve delivery systems
  • Develop deep understanding of procedure through cadaver and animal studies to refine device usage and procedural aspects in partnership with physicians; provide support to clinical trials as needed
  • Generate work instructions, test methods, engineering models and drawings/prototypes to characterize product and process specifications
  • Develop test strategy based on design requirements derived from voice of customer, and execute on protocol, testing, data analysis, and reports required for regulatory submissions
  • Identify issues, conduct root cause analysis, and map out resolution when designing parts, components and sub-assemblies using engineering first principles and appropriate test evaluations
  • Create and update design control documents, including updating risk analysis documents, based upon technical knowledge of device and procedure
  • Develop project plan to manage the work individually and across multiple team members

TECHNICAL SKILLS

Must Have

  • Bachelors degree or higher in Engineering required Minimum of 2 years of experience, or advanced degree

Nice To Have

  • Proficiency with SolidWorks Ability to perform word processing and create spreadsheets.
  • Proficient with computers (i.e.: Word, Excel,etc.)
  • Good problem-solving skills Ability to work well with others
  • Ability to communicate well through written and verbal means
  • Prior internship or co-op experience a plus
  • High level of proficiency in engineering and scientific principles
  • Self-starter and driver – able to execute effectively
  • Excellent communication skills, both written and verbal
  • Flexible and adaptable, comfortable working in a dynamic environment


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