Senior Engineer – Test Method Validation

Position Summary

• We are seeking a Senior Engineer – Test Method Validation to support a critical quality and verification project beginning in September.
• This individual will play a key role in developing, validating, and improving test methods to support medical device Verification & Validation (V&V) activities.
• The ideal candidate has a strong background in test method validation, statistical analysis, technical documentation, and medical device product verification.

Manager Notes:

Required Skills:

• Writes and reviews protocols for Test Method Validation (strong technical writing skills)
• Ability to develop and improve test methods (creative and knowledge of medical device verification)
• Knowledge of statistics and sample size rationales

Preferred Skills (nice to have):

• Quality Background
• Ability to provide guidance to technicians and junior engineers.
• Demonstrates ability to follow Standard Operating Procedures.

Education Requirements:

• Bachelor’s degree in engineering (Mechanical & Biomedical preference)

Key Responsibilities

• Oversees Test Method Validation for V&V
• Demonstrates ability to follow Standard Operating Procedures
• Improves existing Test Methods to make more controllable and remove variability.
• Demonstrates strong statical background for developing sample size rationales
• Writes and reviews protocols for Test Method Validation
• Provide guidance to technicians and junior engineers on test method validation day-to-day tasks is an onsite laboratory-based role working closely with Quality, R&D, and Engineering teams to ensure test methods are robust, repeatable, and compliant with applicable quality standards.

Required Qualifications

• Quality background preferred
• Exceptional analytical and technical writing skills
• Bachelor’s degree in engineering
• Ability to work in Laboratory Environment
• 3 years of experience required in medical device industry