R&D Validation Engineer:: $45/hr. On C2C

Title: R&D Validation Engineer (47317)

Location: Hybrid – 3 days a week on-site in Brea, CA

Duration: 12 months

Visa: USC, GC, OPT/EAD, EAD/GC, H4/EAD,

 

Must Haves…

 

 

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.

 

•        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 company’s brand recognition by writing papers and generating IP (Intellectual Property)

 

Required Qualifications

 

•        Bachelor’s Degree in Mechanical or Biomedical Engineering with a minimum 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.

 

•        Design Verification experience, (Protocol Generation, Report Writing, Testing Strategies)

 

•        Proficient in statistical methods / tools

 

•        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.

 

Preferred Qualifications and Knowledge:

 

•        Graduate degree (MS or Phd) in Mechanical Engineering, Biomedical Engineering or similar

 

•        8+ years of post-educational experience in Medical Device

 

•        Sought as an SME (Subject Matter Expert) in one or more areas expertise

 

Thank & Regards

Sneha Singhal || Technical Recruiter

D: 215-798-9528, E: sneha@firstringsolutions.com

First Ring Solutions LLC | Philadelphia, PA 19102

Note: Due to the high volume of calls, I may miss your call, email is the better way to reach me.