R&D Engineer 2 (12‑month temporary)

About the role

This temporary 12‑month position supports research, design and development projects for medical‑device products. The R&D Engineer 2 will create tooling and fixtures, collaborate with cross‑functional teams, and ensure designs meet regulatory and manufacturing requirements.

Key responsibilities

• Develop and maintain prototype concepts, tooling, drawings and shop orders in coordination with Quality Assurance and Manufacturing.
• Act as liaison between New Product R&D and Manufacturing Engineering, proposing solutions to design, process and quality issues.
• Design and build prototype fixtures, develop test methods, generate protocols and produce verification and validation reports.
• Troubleshoot process and component issues, support process implementation and validation activities.
• Coordinate with external vendors and internal teams for material procurement, testing and documentation of Design History Files per FDA requirements.

Required profile

• Bachelor of Engineering degree.
• Minimum 2 years of relevant experience, including 1‑2 years in the medical‑device industry.
• Familiarity with Good Laboratory Practices and Quality Systems Regulations (QSR).
• Experience with plastics and metal component processing and tolerance stack‑up analysis.
• Fluent in English; Spanish is a plus.

Required skills

• Statistical analysis using MiniTab.
• CAD design with SolidWorks.
• Microsoft Office suite (Word, Excel, Outlook, PowerPoint).
• Measurement and laboratory equipment operation.
• Prototype tooling and fixture design.