Validation Engineer

Company Overview

B&M Precision is an FDA-registered and ISO 13485 certified medical device contract manufacturer committed to producing safe, compliant, and high-quality products. Our quality culture is grounded in robust processes, data-driven decision-making, and continuous improvement.

Position Summary

The Validation Engineer ensures that systems, processes, and equipment meet validation requirements and comply with internal procedures and external standards. This role involves developing validation protocols, performing risk assessments, analyzing test data, producing validation reports, and supporting production activities to maintain product quality and operational efficiency.

        **This is not a remote position**

Key Responsibilities:

• Develop and maintain master validation plans, risk assessments, testing protocols, and related standard operating procedures (SOPs).
• Analyze validation test data to confirm compliance with validation criteria and identify root causes for any issues.
• Prepare detailed reports and design statements based on validation and qualification test results.
• Conduct validation and qualification tests for new or existing processes, equipment, and software in accordance with internal procedures and regulatory standards.
• Communicate effectively with customers to address validation-related inquiries and provide updates.
• Recommend process changes to improve product quality and operational performance.
• Measure product and process performance using customer-provided standards or metrics; perform tests and analyze data to ensure compliance.

B&M Specific Responsibilities:

• Perform Process Capability Analysis and Process Failure Mode and Effects Analysis (pFMEA).
• Conduct Risk Assessments for processes and equipment.
• Develop and execute Equipment Installation and Operational Qualification (EIQ/EOQ) activities.
• Perform Process Characterization studies using tools such as DOEs and fishbone diagrams. 
• Develop robust control strategies for process variables.
• Create and revise Control Plans to ensure process stability.
• Develop and conduct Measurement Systems Analysis (MSA) studies.
• Perform Process Operational and Performance Qualification (OQ/PQ) activities.
• Assist in development of manufacturing equipment and processes to achieve validation requirements.
• Execute Verifiable Process Qualification activities.
• Develop and maintain in-process and final inspection datasheets, Certificates of Conformance (C of Cs), and Certificates of Analysis (C of As).
• Create and review Work Instructions (WI), Preventive Maintenance Plans (PMP), and Standard Operating Procedures (SOPs).
• Review and approve Engineering Change Orders (ECOs).
• Train other members of the Engineering Team on processes and standards.
• Provide production support for Laser Welding, Laser Marking, Electropolish, Passivation, Final Cleaning, and Final Inspection.
• Review and approve Engineering Drawings.
• Support New Product Development (NPD) activities.
• Communicate regularly with customers regarding projects, deadlines, and action items.

Qualifications:

• Bachelor’s degree in engineering, quality assurance, or related field (or equivalent experience).
• Advanced degrees in engineering-related fields are preferred but not required.
• Strong knowledge of validation principles, risk analysis, and quality systems.
• Experience with validation of laser processes, cleaning processes, and special manufacturing techniques preferred.
• Excellent analytical, documentation, and communication skills.
• Experience in medical device manufacturing and ISO 13485 preferred.

Why Join B&M Precision

• Comprehensive medical, dental, and vision benefits.
• Family-owned organization with a strong quality culture.
• Paid vacation, holidays, and PTO.
• Annual bonus, profit sharing, and 401(k) with company match.