R-D Engineer II
3 weeks ago
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
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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