Staff Compliance Validation Engineer

Position Summary:

We are seeking an experienced Compliance and Validation Engineer to lead validation strategy and execution across products, embedded software, hardware, and manufacturing processes. This role is critical to ensure that our technologies meet global regulatory requirements while maintaining the high standards of performance, scalability, and reliability.

As a key partner to R&D and Manufacturing, you will drive a proactive, engineering-focused approach to validation supporting new product introductions (NPI), design transfers, and sustaining operations. This role focuses on executing effective validation activities and supporting the development of efficient, scalable, and audit-ready processes.

Duties & Responsibilities:

• Lead the development and execution of validation strategies, protocols, and reports for equipment, systems, software, and manufacturing processes.
• Own and drive qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), with a focus on production readiness.
• Ensure compliance with applicable regulatory and quality standards (e.g., FDA, ISO 13485) through practical, engineering-driven validation approaches.
• Partner cross-functionally with R&D and Manufacturing teams to support new product introduction (NPI), design verification/validation, and design transfer to production.
• Support integration and validation of hardware/software systems, including test method development and execution.
• Drive validation activities for manufacturing equipment, fixtures, and process development to ensure robust and repeatable production.
• Author, review, and maintain validation documentation, ensuring accuracy, completeness, and audit readiness.
• Support internal and external audits and regulatory inspections, serving as a subject matter expert for validation and compliance activities.
• Develop and maintain SOPs and related documentation and deliver training to ensure consistent understanding and application of validation and compliance requirements.
• Drive continuous improvement in validation and manufacturing processes, leveraging data-driven and engineering best practices.
• Monitor evolving regulatory requirements and industry best practices, recommending and implementing improvements as needed.
• Other duties as needed or required.

Minimum Requirements & Qualifications:

• Bachelor's degree in Engineering, Quality, or a related field; advanced degree preferred
• 8+ years of experience in validation engineering, quality, or compliance within a regulated industry (medical device, pharmaceutical, or biotechnology preferred).
• Strong knowledge of validation principles, including IQ/OQ/PQ, with hands-on experience in software, hardware, and manufacturing environments.
• Solid understanding of regulatory requirements and quality standards, including FDA regulations and ISO 13485.
• Experience with embedded systems, hardware/software integration, and production test methodologies.
• Familiarity with supporting NPI, design transfer, and manufacturing process validation.
• Proficiency with quality management systems (QMS) and validation documentation practices.
• Strong analytical, problem-solving, and organizational skills with high attention to detail.
• Excellent communication and collaboration skills, with the ability to work effectively across engineering and manufacturing teams.

Preferred Qualifications:

• Enterprise Architect
• Markdown
• Quarto
• PowerShell, JavaScript, Typst (and other tools) for automating document generation.