Design Engineer
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.