Test Method Validation Engineer

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

We are seeking a Senior Test Method Validation Engineer to support product development for next-generation transcatheter valve technologies. This role will focus on test method development and validation, testing, statistical analysis, and engineering support within a regulated medical device environment.

Skills & Qualifications:

• Lead test method validation protocol development, execution, statistical analysis, and reporting
• Develop and validate test methods and models
• Perform testing and data analysis to support product and process development
• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field
• 7+ years of engineering experience in design, testing, manufacturing, or engineering support
• Strong experience with test method validation and data analysis
• Knowledge of MSA, metrology, and Gage R&R
• Strong communication, organization, and problem-solving skills
• Ability to work independently and within cross-functional teams
• Medical device or regulated-industry experience preferred
• SolidWorks/CAD experience is a plus
• Experience with Windchill or electronic document control systems preferred