Job Details

Must Have:
Root cause investigation experience, Catheter design, Test Method Development

Nice to Have:
Nitinol experience, Design Verification, Design Validation, Fixture Design, Polymer materials

JOB DESCRIPTION
HM's Top Needs:
1. Catheter development experience
2. Test method development and validation experience
3. Proven Root cause investigation experience

Education Required: Requires a University Degree (Mechanical Engineering, or related technical field) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Years' Experience Required:
Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40 hours/week will be expected
Work Location:
Do they need to be local to any MDT office and if so where? Yes. Santa Rosa, California.
Does this person need to be on site? If so, full time or part time? Yes. Full Time.

Serve as a technical expert in the development of engineering solutions for a derivative product line. Support the R&D technical team through planning, developing, and performing testing and analysis. Provide recommendations based on in-depth analysis. Partner with Quality Engineering, Operations, Regulatory, and Marketing. This role is within ***'s Peripheral Vascular Health operating unit, which employs the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. We focus on transforming global vascular disease management.
Responsibilities include:
Develop and coordinate small projects, as asked by the project team.
Understand the requirements of cross-functional internal customers.
Apply technical principles, theories, and concepts in the R&D engineering field.
Create and document test plans/protocols, perform testing, and analyze and document results.
Facilitate design sample preparation and testing. Electrical laboratory equipment typically used includes oscilloscopes, electrical safety test equipment, thermocouple calibration, variable impedance loads, and others.
Apply statistical techniques and interpret test results.
Generate engineering change orders (Agile PLM).
Complete tasks associated with area of responsibility within assigned schedule.
Present technical findings or task status to cross functional teams through meeting minutes, presentations, design reviews and other means of communication.
Maintain required documentation per GDP procedures.
Perform job functions in accordance with applicable GMP, IEC and ISO standards.
Specialized Knowledge or Skills:
Experience in the Medical Device Industry (catheter experience preferred);
Experience developing products in the R&D function;
Experience with Design Verification Testing;
Experience with Test Method development and validation;
Technical writing skills (DVT protocol and reports, engineering rationales, etc.);
Experience using statistical techniques (e.g. use of statistical software like Minitab, DOE, ANOVA, etc.);
Demonstrated problem solving skills;
Demonstrated leadership and initiative.

Requires a University Degree (Mechanical Engineering, or related technical field) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.