Project Engineer

$96 - $100 per hour

TPS Group Company

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

MUST HAVE SKILLS:
• 10+ years of experience as a Project Engineer
• 3-5+ years of experience as a Device Engineer on an injectable combination product development product.
• Direct experience developing design controls for autoinjectors and syringe products.
• Ability to discuss examples of design requirements documents, risk management files, trace (traceability matrix), specifications, design outputs, and drawings.

Apply

Vacancy posted 3 days ago

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