Senior Validation Engineer

Test Method Validation Engineer

This Test Method Validation Engineer role focuses on leading test method validation activities within a verification and validation (V&V) environment for medical devices. The position requires a strong technical writing experience, solid understanding of statistics, and hands-on experience improving and developing test methods to ensure reliable, repeatable, and compliant testing. The engineer will collaborate closely with technicians and junior engineers, provide day-to-day guidance, and support quality assurance objectives in an office and laboratory setting.

Responsibilities:

• Oversee test method validation activities for verification and validation (V&V) of medical devices.
• Develop, improve, and optimize existing test methods to increase control and reduce variability.
• Write clear, detailed, and compliant protocols for test method validation.
• Review test method validation protocols to ensure accuracy, completeness, and adherence to procedures and regulatory expectations.
• Demonstrate and apply a strong statistical experience to develop sample size rationales and support data-driven decisions.
• Follow established Standard Operating Procedures (SOPs) and ensure that all test method validation activities comply with them.
• Provide day-to-day guidance and technical support to technicians and junior engineers on test method validation tasks.
• Support verification testing and validation testing activities in alignment with quality assurance requirements for medical devices.
• Collaborate with quality and engineering teams to ensure test methods meet product and regulatory requirements.
• Document test results and validation outcomes accurately and maintain organized records for audits and reviews.

Essential Skills:

• Proven experience overseeing test method validation for verification and validation (V&V) in the medical device industry.
• Strong technical writing skills with the ability to write and review detailed protocols for test method validation.
• Ability to develop and improve test methods, including knowledge of medical device verification processes.
• Solid statistical experience, including the ability to develop and justify sample size rationales.
• Demonstrated ability to follow Standard Operating Procedures (SOPs) consistently.
• At least 3+ years of experience in the medical device industry.
• Bachelor's degree in Engineering.
• Ability to work effectively in a laboratory environment.
• Experience with verification testing, validation testing, and quality assurance in a medical device context.

Additional Skills & Qualifications:

• Quality experience preferred, including familiarity with quality assurance principles and practices.
• Exceptional analytical skills with the ability to interpret data and draw meaningful conclusions.
• Experience providing guidance and mentorship to technicians and junior engineers.
• Strong attention to detail and commitment to maintaining high standards of documentation and compliance.
• Ability to collaborate across cross-functional teams in engineering and quality.
• Comfort working in both office and laboratory environments.

Work Environment:

The role operates in a combined office and laboratory environment within a stable medical device organization. You will spend time in the lab performing or supporting test method validation activities, working with test equipment, and following established laboratory procedures. In the office setting, you will focus on technical writing, data analysis, and collaboration with engineering and quality teams. The environment emphasizes adherence to Standard Operating Procedures, data integrity, and a strong quality culture.

Job Type & Location:

This is a Contract position based out of North Andover, MA.

Pay and Benefits:

The pay range for this position is $60.00 - $80.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type:

This is a fully onsite position in North Andover, MA.

Application Deadline:

This position is anticipated to close on Aug 28, 2026.