Mechanical Engineer 100 Remote

Mechanical Engineer 100 Remote

Required Qualifications

• 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.

Preferred Qualifications

• 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.

Key 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.

Interview Process

• One-round interview conducted via Microsoft Teams with the hiring manager.
• Behavioral and technical questions will focus on problem solving, DFMEA experience, regulated product development, communication style, and ability to manage competing priorities.