Validation Engineer

Responsibilities:

• Lead Continuous Improvement (CIP) projects in collaboration with cross-functional internal teams and external suppliers.
• Perform CIP calculations, including supplier quotation evaluations and cost-benefit analysis.
• Develop and manage project budgets covering feasibility studies, capital equipment, validation costs, DVT samples, and related testing requirements (e.g., bioburden).
• Create detailed project plans using Microsoft Project and prepare presentation materials using PowerPoint.
• Demonstrate understanding of product electrical design, system architecture, and functional performance.
• Lead design changes, component substitutions, and supplier transitions to achieve cost savings and improved performance (Type II savings).
• Develop strategies to meet CIP targets and drive continuous improvement initiatives.
• Conduct engineering testing, develop test protocols, prepare test reports, and participate in design reviews.
• Oversee project execution including timelines, dependencies, and task coordination.
• Identify appropriate electrical test methods and collaborate with R&D teams to align requirements.
• Review engineering requirements, support process validation activities, and finalize validation documentation (e.g., RR forms, validation reports).
• Execute change control processes and supplier change requests.
• Communicate technical issues, risks, and opportunities to management.
• Ensure compliance with Health, Safety, Environmental, and regulatory requirements.
• Maintain adherence to federal, state, local, and company procedures.
• Provide technical guidance or supervision to junior engineers or technicians as needed.

Requirements:

• Bachelor's degree in Electrical Engineering, Mechanical Engineering, Software Engineering, or related Engineering discipline.
• 3 5 years of relevant experience in validation engineering, product engineering, or manufacturing engineering within a regulated industry.
• Experience in medical device or similarly regulated environments preferred.
• Strong understanding of validation processes, process engineering, and engineering documentation.
• Experience with Continuous Improvement (CIP), supplier coordination, and project execution is highly desirable.
• Familiarity with product design, electrical systems, and engineering test methods is preferred.
• Proficiency in Microsoft Project and PowerPoint is an added advantage.
• Strong knowledge of regulatory requirements and quality systems in a manufacturing environment.