Senior Research And Development Engineer

4 weeks ago


Santa Rosa, United States Planet Pharma Full time

This is a long-term W2 contract position at a leading medical device company, ON-SITE in Santa Rosa, CA. Benefits are available. Engineering experience in the Medical Device industry in root cause analysis, test method development, and fixture/mechanical component design is required (this is not an IT role).


  • Title: Sr. R&D Engineer
  • Company Type: Medical Devices
  • Initial Contract Duration:1-year with potential to extend longer or be hired on FTE down the road based on performance and business
  • Hours: 40-hours per week, M-F, standard office hours
  • Benefits: Medical, Dental, Vision Insurance, 401K match, Supplemental (Life, Accident, etc) available through Planet Pharma


Top Required Skills

  • Medical Device or Biotech industry experience
  • Experience performing Root Cause Analysis
  • Hands-on experience with Test Method development, fixture design, and mechanical component design.
  • Bachelors degree with 4+ years of relevant experience OR advanced degree with 2+ years


Job Responsibilities:

  • Design, develop and optimize transcatheter heart valve catheter 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
  • Manage product interfaces across implant, catheter, accessories and packaging, including setting up requirements flow and ensuring design changes are properly evaluated
  • Generate work instructions, test methods, engineering models and drawings/prototypes to characterize product and process specifications
  • Develop test methods to verify product performance is as intended
  • 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
  • Support delivery system builds by addressing questions, conducting root cause analysis as required and leading issue resolution
  • Support clinical trials through physician/site training and providing case support
  • Develop project plan to manage the work individually and across multiple team members
  • Contribute to defining the direction for new products, processes, standards, or operational plans based on business strategy
  • Communicate with internal and external customers and vendors at various levels; represent work through internal conferences and collaborations across multiple business units and functions.


Skills:

Must Have

  • • Bachelors degree in a technically related field required • Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience


Nice to Have:

  • Experience in test method development
  • Degree in Mechanical, Materials or Biomedical Engineering
  • Proficiency with SolidWorks
  • Catheter design and development experience
  • Experience with hydraulics is a bonus
  • Ability to perform word processing and create spreadsheets. Proficient with computers (i.e.: Word, Excel,etc.)
  • Good problem-solving skills
  • Knowledge of statistical methods
  • Ability to work well with others
  • Ability to communicate well through written and verbal means
  • Skilled in project management and planning
  • Self-starter and driver – able to execute effectively
  • Excellent communication skills, both written and verbal
  • Flexible and adaptable, comfortable working in a dynamic environmen



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