Sr. Mechanical Engineer
4 weeks ago
Senior Mechanical Engineer
My client is looking for a Sr. Mechanical Engineer to perform research and development activities for endovascular guidewires/catheters for their Houston offices. This company serves a global network of hospitals and medical facilities in a 100+ countries with a growing team of 1,000+ employees.
Job Functions
- Conducts research and development activities
- Conducts technical risk management activities, proof of concept design, prototype design and testing in accordance with design verification and validation requirements
- Develops and improves manufacturing processes
- Manages the adherence to procedures to ensure product quality meets or exceeds planned goals
- Develops and executes design verification and design validation protocols and reports
- Assures product and process quality by designing testing methods; testing finished product and process capabilities, establishing standards, confirming manufacturing processes
- Is aware of and complies with regulatory requirements (21 CFR 820, ISO 13485)
- Participates in quality control/assurance related activities
Essential Requirements
- Bachelor’s Degree in Mechanical, Biomedical, Materials Engineering or related
- 5-10 years of experience in the medical device industry in R&D setting
- R&D experience with endovascular guidewires and catheters, preferably steerable guidewires
- SolidWorks CAD experience
- Ability to articulate clearly, professional oral and written communication skills
- Must be proficient in general computer programs such as Microsoft Office
- Strong planning, technical, and problem-solving skills
- Ability to understand and create engineering schematics
- Familiarity with ISO 13485, 21 CFR Part 820 QSR.
Location
Houston, TX
If you're interested in hearing more about this position and company, please send an updated resume to Patrick.Kelly@lumicity.io
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