Hi,
Hope you are doing well.
I have an urgent opening of R&D Engineer at Valencia, CA
Position Type: Contract
Location: Valencia, CA, United States
Description:
Interview : Video
This is hybrid from day-1 ( Need local candidates )
Position Overview
A senior-level R&D Engineer is needed to support design control activities, test method development, and mechanical design work for regulated medical device products. This role involves developing and validating test methods, designing fixtures and tooling in SolidWorks, updating product drawings, and generating traceable documentation such as specification maps and DFMEAs. The position requires strong technical expertise, crossfunctional collaboration, and the ability to manage multiple engineering activities with limited supervision.
This is a contract assignment expected to conclude by late September 2026.
Key Responsibilities
Design Control & Technical Execution
- Lead design control activities, including developing requirements, sourcing requirements, creating and validating test methods, generating risk documentation, and performing required testing.
- Compile, analyze, and report test, research, and operational data to establish performance standards for new or modified products, materials, and processes.
- Design and develop fixtures, tooling, and test equipment using SolidWorks.
- Update and maintain product drawings and documentation in SolidWorks.
- Ensure product safety, quality, and regulatory compliance throughout all engineering activities.
Project & CrossFunctional Collaboration
- Provide engineering oversight across design, quality, manufacturing, and projectrelated functions.
- Coordinate with internal teams and external suppliers to identify, plan, and execute engineering projects.
- Support manufacturing transfers between vendors.
- Apply project management and problemsolving skills to manage multiple concurrent activities.
- Participate in R&D project planning and execution as needed.
- Support additional engineering and business activities as assigned.
Quality & Compliance
- Maintain compliance with all applicable quality system regulations, including FDA QSR and ISO 13485.
- Utilize changemanagement processes (DCA, SCIA, SCAR, PLCP).
- Conduct troubleshooting and rootcause analysis for design and process issues.
- Build quality into all aspects of work by adhering to established quality requirements.
Required Qualifications
- 5+ years of experience working with design controls.
- 5+ years of experience within FDA Quality System Regulations and ISO 13485.
- Experience assessing quality and compliance impacts for design and process changes.
- Strong background in design verification and validation activities.
- Experience developing test methods.
- Proficiency in troubleshooting and rootcause analysis.
- Ability to work independently and manage complex tasks.
- Working knowledge of MiniTab and SolidWorks.
- Strong written and verbal communication skills, including assessments, protocols, and technical reports.
Preferred Qualifications
- Leadership experience on 4+ projects involving product or process design changes.
- 3+ years of mechanical design experience.
- Participation in multiple new product development projects, including product transfer and scaleup.
- Experience with SAP and Windchill.
- Experience in Human Factors / Usability engineering.
Education
- BS degree with 5 8 years of experience
- MS degree with 3 6 years of experience
- PhD with 0 3 years of experience
Regards,
Nitin Gupta
Team Lead-Recruitment
ShiftCode Analytics Inc.,
5118 Sylvester loop Tampa,
Florida 33610
Direct:
Email:
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