Sr R/D Engineer - Exempt - LanceSoft Inc
Santa Rosa, CA 95403
About the Job
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 environment
JOB DESCRIPTION
HM's Top Needs:
Candidate with some level of industry experience in Bio-Tech or Medical Devices industry
Good problem solving skills with experience in performing root-cause analysis
Hands-on experience with test method development, fixture design and mechanical component design
Education Required: Bachelors degree in a technically related field required preferably mechanical engineering or biomedical engineering
Years’ Experience Required: Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes 40 hrs a week
Work Location:
Do they need to be local to any MDT office and if so where? Yes to Santa Rosa, California
Does this person need to be on site? If so, full time or part time? Yes, full time
A Day of in the Life:
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.
• 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 environment
JOB DESCRIPTION
HM's Top Needs:
Candidate with some level of industry experience in Bio-Tech or Medical Devices industry
Good problem solving skills with experience in performing root-cause analysis
Hands-on experience with test method development, fixture design and mechanical component design
Education Required: Bachelors degree in a technically related field required preferably mechanical engineering or biomedical engineering
Years’ Experience Required: Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes 40 hrs a week
Work Location:
Do they need to be local to any MDT office and if so where? Yes to Santa Rosa, California
Does this person need to be on site? If so, full time or part time? Yes, full time
A Day of in the Life:
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.
Source : LanceSoft Inc
