Description

You lead quality assurance for medical device product development, ensuring compliance with regulatory standards and driving risk management processes.

This role is on-site.

Responsibilities

• Lead project teams in executing design assurance deliverables, including Design Verification, Reliability Validation, and Usability Validation plans.
• Evaluate risk documentation and post-market records (PIR, CAPA, Field Actions) to support remediation and compliance.
• Develop solutions for complex technical problems, analyzing data to influence cross-functional project strategies and decisions.
• Maintain compliance with quality requirements, defending team work and supporting internal and external regulatory audits.

Required Skills

• 5+ years of experience in design assurance, new product development, or the regulated medical device industry.
• Deep understanding of electrical safety standards, specifically IEC 60601.
• Proficiency with reliability testing methodologies and tools.
• Strong knowledge of Risk documentation per ISO 14971 and Quality System Regulations (QSR).
• Demonstrated use of Quality tools and methodologies.
• Bachelor’s degree in mechanical, electrical, biomedical engineering, or related discipline.
• Strong written and verbal communication skills to elevate issues and guide project decisions.

Preferred Skills

• Experience with Class III medical devices and previous R&D experience.
• ASQ certification.

Key Skills

Education

Bachelor's degree