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Senior R&D Catheter Engineer
152174
Posted:
10th November 2024
- 120000 USD - 150000 USD
- Irvine, United States
- Permanent
Meet has recently partnered with a small but exciting medical device start-up based in Orange County, CA. With their most recent financial funding, the company plans to quickly expand their team to accelerate & broaden product development efforts. The company is developing market disrupting surgical devices using their novel intravascular ultrasound technology.
The senior leadership team is looking to hire a Senior Research & Development Engineer to act as a technical lead for the catheter development group. This role will require a strong background in Mechanical/Biomedical Engineering and 5-10 years of R&D experience in the medical device industry. An ideal candidate would have an expertise in electrophysiology ablation catheter design and development and demonstrated experience developing complex electromechanical systems and class II/III devices from concept to product launch.
***Onsite position; Local Candidates Preferred
ROLE RESPONSIBILITIES:
- Act as Technical Leader and work cooperatively with quality, manufacturing, regulatory, and marketing on complex projects to ensure project success
- Consistently generate innovative and unique solutions to market needs by collaborating with KOLs.
- Select techniques to solve complex problems and make sound design recommendations
- Design and prepare complex reports to communicate results to technical community
- Own components, MPIs, STMs, supplier relations, and data presentation
- Design prototypes using CAD and follow through to manufacturing, utilization & characterization, and next-generation equipment & devices
- Develop test methods, protocols, reports, and conclusions to evaluate components, processes, and assemblies
- Create manufacturing documentation, including Manufacturing Process Instructions and Bills of Materials
- Work closely with Q/A to develop standards, perform verification and validation testing, perform failure analysis, and to continuously improve the company’s products and processes.
- Work effectively within the confines of a regulated, quality-system driven, FDA monitored medical device environment.
QUALIFICATIONS:
- B.S./M.S. in Mechanical or Electrical Engineering or equivalent
- at least 5-10 years of hands-on experience in the Medical Device Industry working within R&D/Product Development. Cardiovascular Catheter development experience required. Electrophysiology ablation catheter design experience strongly desired.
- Strong mechanical engineering experience, specifically with catheters, machined and injection molded components, design for manufacturability, proficiency with SolidWorks/CAD
- Demonstrated ability to bring products from concept to market; Strong understanding of all elements (design and design controls) required to take a product from feasibility to launch
- Start-up company experience strongly desired
- Strong clinical background with a thorough knowledge of anatomy and disease, exposure to doctors, and surgical procedure development
- Medical device manufacturing and process development experience
- Experience with medical device quality systems, V&V studies, and regulatory filings