Job Title: Senior Engineer – Test Method Validation
Location: North Andover, MA (Onsite)
Duration: 6 Month Contract (Potential Extension)
Schedule: Monday – Friday | 40 hours/week | Core business hours (8:00 AM – 5:00 PM with 1-hour flexibility)
Pay Range: $90-$100/hr
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