Qualifications

• Bachelor's Degree or Technical Degree in Engineering.
• Minimum 5 years of experience in medical device manufacturing, quality, or product development; catheter experience preferred.
• Knowledge of FDA/cGMP and MDD regulations and guidelines, as well as International Standards.
• Experience in design verifications and validations.
• Proficient in Risk Management throughout product lifecycle.
• Familiarity with Quality Management System software.
• Strong project management skills and ability to prioritize multiple tasks.

Responsibilities

• Manage design process deliverables including DHF and project documentation.
• Collaborate with design teams on verification and validation protocols.
• Ensure documentation of product and quality requirements within design teams.
• Assist in FMEA and Hazard Analysis development with engineering departments.
• Implement and guide Incoming Inspection and product inspection plans.
• Lead the creation of quality plans specific to projects.
• Train employees on quality-related activities.

Benefits

• Work in a collaborative cross-functional team environment.
• Opportunity to contribute to medical device product development from concept to commercialization.
• Engagement in hands-on quality assurance processes and methodologies.
• Involvement in diverse projects with varying complexities.