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