Research And Development Engineer

Project Engineer -- Medical Device & Combination Products

Location: 100% Remote

Duration: 5-Month Contract (Potential Extension/ Conversion)

Pay Rate: $96 - 100/hour

Position Summary

Our client is seeking an experienced Project Engineer to support medical device and combination product development activities. This role will focus on design control, risk management, verification testing, and regulatory support for device-related projects within a regulated environment.

Key Responsibilities

• Lead and support device and combination product development activities
• Manage design control documentation, DHF, risk assessments, and traceability
• Develop and execute design verification testing and test methods
• Support regulatory submissions and compliance activities
• Coordinate with cross-functional teams, vendors, and CMOs/CDMOs
• Support human factors engineering studies and manufacturing activities
• Author technical documents including protocols, reports, SOPs, and work instructions
• Drive product and process improvements through change control processes

Required Qualifications

• BS in Engineering or related field required; MS preferred
• 8--10+ years of medical device or combination product development experience
• Strong experience with:
  • Design controls
  • Risk management (DFMEA, PFMEA, UFMEA)
  • Design verification & validation
  • DHF documentation
  • Regulatory standards (FDA, ISO, cGMP, QSR)
• Experience working with external vendors, CMOs, or CDMOs
• Strong communication and project coordination skills

Preferred Experience

• Auto injectors, prefilled syringes, needle safety devices, or on-body devices
• Human factors engineering support
• Design for Manufacturability (DFM) and Design for Assembly (DFA)
• SolidWorks or similar design software experience