Remote- Mechanical Engineer

Apetan Consulting LLC is seeking a Mechanical Engineer to support product development activities. The role involves leading DFMEA reviews, developing testing documentation, and collaborating with cross-functional teams to ensure quality and regulatory compliance.

Responsibilities:

• Support DSx product development activities throughout the product lifecycle
• Lead and participate in DFMEA reviews and risk management activities
• Develop, execute, and document verification and validation testing
• Create and maintain technical documentation in accordance with quality and regulatory requirements
• Collaborate cross-functionally with engineering, quality, regulatory, and manufacturing teams
• Troubleshoot technical issues and drive root cause investigations
• Support design reviews and continuous improvement initiatives

Requirements:

• Bachelor's Degree in Mechanical Engineering required
• Minimum 3 years of mechanical engineering experience in a product development environment
• Experience working through the Product Development Lifecycle (PDLM)
• Experience with Design Failure Mode and Effects Analysis (DFMEA)
• Experience supporting design verification and validation activities
• Strong technical documentation and engineering change management experience
• Medical device industry experience strongly preferred
• Experience working within FDA-regulated or other highly regulated environments
• Experience using Creo for mechanical design and engineering documentation
• SAP experience, particularly for engineering documentation and document management
• Windchill experience is a plus