Associate Validation Engineer

Associate Validation Engineer (Electrical or Mechanical Focus)

Location: MA

• Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Support process validation and equipment qualification activities for manufacturing operations.
• Develop, execute, and document Test Method Validation (TMV) protocols.
• Perform and support inspection method validation activities.
• Generate, execute, and summarize validation protocols and final reports.
• Analyze validation data and prepare technical documentation.
• Participate in root cause investigations and implement corrective actions related to validation activities.
• Collaborate cross-functionally with Quality, Manufacturing, Engineering, and Operations teams.
• Support remediation projects and continuous improvement initiatives.
• Maintain validation documentation in compliance with FDA Quality System Regulations (21 CFR Part 820) and applicable ISO standards.

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, or a related engineering discipline.
• 5–8 years of validation experience within the medical device industry.
• Demonstrated experience with:
• Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Process Validation
• Equipment Qualification
• Test Method Validation (TMV)
• Inspection Method Validation
• Working knowledge of FDA Quality System Regulations and ISO requirements.
• Strong analytical, technical writing, and documentation skills.
• Ability to work effectively in a cross-functional, fast-paced manufacturing environment.

• Bachelor's degree in Electrical Engineering.
• Experience in electronics or electromechanical medical device manufacturing.
• Hands‑on soldering experience.
• Experience validating electrical inspection and test equipment.
• Familiarity with electronic assembly and manufacturing processes.

• Bachelor's degree in Mechanical Engineering.
• Experience validating mechanical manufacturing and assembly processes.
• Hands‑on soldering experience is preferred.
• Experience with assembly process validation and manufacturing equipment qualification.
• Knowledge of mechanical production processes within a regulated manufacturing environment.