Project Engineer

Tucker Parker Smith Group (TPS Group)

San Rafael, CA(remote)

JOB DETAILS
SALARY
$96–$100 Per Hour
SKILLS
CMOS, Change Control, Communication Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Design Document, Design Failure Mode and Effects Analysis (DFMEA), Design Verification, Design for Assembly (DFA), Document Management, FDA Requirements, Human Factors, ISO (International Organization for Standardization), Manufacturing, Manufacturing Design, Medical Equipment, Medical Office Administration, Organizational Skills, Process Failure Mode and Effects Analysis (PFMEA), Process Improvement, Product Development, Project Engineering, Project/Program Coordination, Quality Assurance Methodology, Quality System Requirements (QSR), Regulations, Regulatory Compliance, Regulatory Submissions, Requirements Management, Risk Analysis, Risk Management, Software Design, SolidWorks, Standard Operating Procedures (SOP), Technical Writing, Test Design, Testing, Traceability, Validation Testing, Writing Skills
LOCATION
San Rafael, CA
POSTED
23 days ago

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.

About the Company

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Tucker Parker Smith Group (TPS Group)