Lead Risk Management activities including analyzing field data to support Failure Mode Effects Analysis and Hazard Analysis.
Support Test and Inspection Method development including Method Validation activities.
Support Design Verification and Design Validation planning and execution, including cross-functional root-cause analysis investigation and resolution activities.
Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory / standards compliance; collaboratively identifying, communicating, and resolving gaps.
Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.
Own Corrective Action/Preventive Action (CAPA) investigations.
Required Qualifications:
Bachelor's degree within an Engineering field or a closely related discipline.
5-8+ years of medical device engineering experience and demonstrated use of Quality tools/methodologies.
Preferred Qualifications-Can Modify
Bachelor's or advanced degree in Mechanical or Biomedical Engineering
Prior experience with Cardiovascular medical devices
Familiar with 21 CFR Part 820, ISO 13485, ISO 14971, EUMDR, and MDSAP.
Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.