Design Engineer

Design Engineer

Location: Jacksonville, FL Employment Type: Contract (Multi-year project)

Job Description

We are seeking a dedicated and skilled Design Engineer to join our team for a multi-year project following the acquisition of a new surgical company. The candidate will play a crucial role in the remediation of the product, focusing on conducting a full review of the Design History File (DHF). This includes setting and reviewing design inputs and outputs for any necessary product changes.

Key Responsibilities

• Conduct a thorough review of the Design History File (DHF) for the acquired product.
• Perform gap analysis to identify areas for improvement or compliance.
• Define and set design inputs and outputs for changes in the product DHF.
• Collaborate with cross-functional teams, including product development, quality, and regulatory teams.
• Ensure all design changes follow Design Control processes and are compliant with regulatory standards.
• Participate in FMEA (Failure Modes and Effects Analysis) sessions to assess risk and improve product design.
• Utilize 3D modeling software to develop and modify designs as needed for product improvements.

Top Skills

• DHF / FMEA
• Product Development
• Gap Analysis
• Design Controls (Input/Output)
• 3D Modeling

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Proven experience with Design History Files (DHF) and working within medical device or surgical industries.
• Familiarity with FMEA and other risk management techniques.
• Strong understanding of design controls and experience setting design inputs/outputs.
• Proficiency in 3D modeling software, such as SolidWorks, Creo, or AutoCAD.
• Ability to work on multi-disciplinary teams and communicate effectively with stakeholders.