Validation Engineer
Hi,
Hope you are doing well,
Please go through the job description and if interested please reply along with your RESUME & EXPECTED RATE.
Job Title : Validation Engineer
Location: Brea, CA (Hybrid)
Duration : Long Term Contract
Local to CA Only
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
Thanks & regards
Rajiv Pathak
Cell: 703 813 6426
Email: rajiv@cy-tec.com
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