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Senior Research And Development Engineer
4 weeks ago
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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