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R&D Product Development Engineer Location: Brea, CA, 3 days/week onsite
Overview:
Research and Development Engineering is responsible for developing and implementing new products through adherence to established design control processes and good engineering and documentation practices.
While maintaining a Customer Focus, responsibilities include (but are not limited to): Strategy development and Execution for Qualification of Medical Devices inclusive of Design Verification, Design Validation and Design Transfer activities.
The R&D Senior Engineer will impact healthcare business groups by driving commercialization of new products and design changes for current products through development, qualification and launch phases.
The R&D Senior Engineer contributes to building organizational effectiveness through creating, leveraging and sharing best practices; seeking and providing training; driving technical and workflow innovation.
Duties
Creating, editing, and interpreting technical drawings
Design Verification Strategy Development
Functional Device Testing
Testing by Analysis
Design Validation Strategy Development
End User Validation Testing
Technical writing (protocols, reports, work instructions, presentations, etc.) and effective verbal communication
Expert application of engineering principles for design / analysis
Statistical analysis and sample plan development
Identifies external technologies
Identifies critical strengths and weaknesses
Nurtures IDR's (Invention Disclosure Records) from infancy
Continuous Learning
Participates in external activities to enhance the brand recognition of BD by writing papers and generating IP (Intellectual Property)
Required Qualifications
Bachelors Degree in Mechanical or Biomedical Engineering with a min.of 6+ years of experience in medical device or other regulated industry OR Advanced Degree in Mechanical or Biomedical Engineering.
Track record of technical problem solving and effective product development.
Design controls expertise for Medical or regulated industry experience.
Proficient in solid mechanics / mechanics of materials
Familiarity with traditional and modern fabrication techniques
Knowledge of regulatory standards applicable to design of medical devices, including FDA QSR 21 CFR 820, ISO 13845, ISO14971 and ISO 80369 and collateral standards.
Ready to kickstart your career in the vibrant city of Brea, California? This bustling community in Orange County is a hub of growth and opportunity, making it an ideal location for job seekers looking to thrive. With its proximity to stunning beaches, world-class entertainment venues like the Brea Mall, and renowned art galleries such as the City of Brea Art Gallery, there's no shortage of charm and culture in this picturesque area. Explore our diverse job opportunities and embark on a career journey in a place known for its unique blend of urban amenities and outdoor recreation, making it a standout choice for professionals looking to grow both personally and professionally.
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