Sr. R&D Engineer

Company Info
AccuMedical USA Inc
Costa Mesa, CA, United States

Phone: 7149291020
Web Site: https://www.linkedin.com/company/76580994/

Company Profile
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Title:

Sr. R&D Engineer

Location:

Costa Mesa, CA 

Salary:

80,000 to 150,000

Job ID:

67950
col-wide   

Job Description:

AccuMedical USA Inc. is looking for an R&D Engineer to join our innovative and dynamic team in Costa Mesa, California.

AccuMedical is focused on developing innovative therapies for neurovascular products that will address global unmet medical conditions and patient needs. This position is part of a New Product Development (NPD) team, primarily responsible for front-end innovation and design, delivering novel products to address unmet needs. As a thriving small business with global thinking, we work in a fast-paced environment, empowering our team members to contribute and lead with opportunities to excel and grow in their expert fields. We believe in work/life balance and wellness for our employees.

Essential Responsibilities of the R&D Engineer include:

· Lead New Product Development (NPD) projects to develop concepts and new devices

· As a front-end lead R&D NPD team member, work with cross-functional team members to bring new products that comply with internal QMS and applicable regulatory requirements

· Lead the development and testing of prototypes, tools and fixtures

· Establish design control documents, risk documents and conduct design review meetings as planned

· Through quality planning, perform design verification and validation operations, including scale up and optimization of processes, equipment and tools, using the latest technologies to enhance product quality and to design for manufacturability and cost-efficient production

· Generate or assist with generating of IP through collaboration with patent attorney

· Plan for pre-clinical activities and generate technical reports to support product submission

· Identify issues proactively and use an engineering methodical approach to resolve design, subsystem, components and process problems

· Work with suppliers on procurement of components, tools and equipment for testing and inspection.

Education and Experience:

· Must be eligible to work in the U.S. and not require visa sponsorship

· Bachelor’s Degree in Engineering or another Scientific discipline with a minimum of 5 years of experience

· Knowledge in research and development of catheters or implantable devices is a plus

· Working knowledge of Medical Device regulations for FDA 21 CFR 820 (QSR)

· Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering

· Working knowledge and understanding of statistical techniques

· Strong technical writing, documentation, communication and interpersonal relationship skills

Please send your resume to the messaging link above.