Description

You will own design quality processes for medical device development projects.

This role is on-site.

Responsibilities

• Manage Design Change, Clinical, and New Product Development projects within the medical device scope.
• Compile Design History Files and Technical File submissions for 510k and CE mark clearances.
• Own and generate Risk Management files, including Hazard Analysis, DFMEA, and Risk Management reports.
• Execute and support Design Control processes, covering Design Input, Design Outputs, Verification, and Validation.
• Review and approve design history files across cross-functional teams, including software deliverables.

Required Skills

• 6+ years of experience in Medical Devices Design Quality.
• Expertise in Medical Device regulations: ISO13485, FDA, and EU MDR.
• Proficiency in Risk Management methodologies.
• Experience with Dfmea.
• Strong technical documentation skills for medical devices.
• Ability to work with cross-functional teams to execute design controls.
• Proven analytical, problem-solving, and critical thinking abilities.

Key Skills

Education

Any Gradute