Senior Test Method Validation Engineer – Medical Devices

United Pharma; California; On-site; USD 110,000 - 160,000; Full time

Job summary

United Pharma is seeking a Senior Test Method Validation Engineer to advance next-generation transcatheter valve technologies. You will lead test method development, validation, testing, and data analysis in a regulated medical device environment.

Responsibilities include developing validation protocols, performing statistical analysis, and providing engineering support to cross-functional teams, with emphasis on accuracy, documentation, and compliance.

Qualifications

• Lead development and validation of test methods and protocols.
• Perform testing and data analysis to support product development.
• Bachelor’s in Mechanical or Biomedical Eng.
• 7+ years engineering experience in design, testing or manufacturing.
• Experience with MSA, metrology, and Gage R&R.
• Regulated medical device environment experience preferred.
• Strong communication and cross-functional teamwork.
• CAD/CAE tools like SolidWorks.

Responsibilities

• Lead test method validation protocol development, execution, and reporting.
• Develop and validate test methods and models.
• Perform testing and data analysis to support product development.
• Provide engineering support for product and process development.

Skills

Test method validation

Data analysis

Statistical analysis

Communication

Independent work

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field

Tools

SolidWorks/CAD

Windchill

Job description

United Pharma is seeking a Senior Test Method Validation Engineer to advance next-generation transcatheter valve technologies. You will lead test method development, validation, testing, and data analysis in a regulated medical device environment.

Responsibilities include developing validation protocols, performing statistical analysis, and providing engineering support to cross-functional teams, with emphasis on accuracy, documentation, and compliance.