Principal Product Engineer

Responsibilities

• Lead investigations of product issues, complaints, and non-conformances
• Perform root cause analysis and support CAPA activities
• Support risk management and design control activities
• Lead process validation efforts (IQ/OQ/PQ) and production controls
• Collaborate with Quality, Regulatory, and Product Development teams
• Ensure compliance with ISO 13485 and FDA 21 CFR 820 Qualifications
• Bachelor’s degree in Mechanical, Biomedical, or related Engineering field
• 10+ years of experience in medical device or regulated manufacturing
• Strong knowledge of risk management, validation, and quality systems
• Excellent problem-solving and cross-functional collaboration skills #J-18808-Ljbffr