Director of Engineering

Permanent, Director of Engineering, Combination Products

Summary

Our client, a small, growing medical device organization, has engaged GForce Life Sciences to provide a Director of Engineering. This role combines people leadership, technical authority, client engagement, and operational ownership. The ideal candidate has deep experience developing drug-device combination products and can lead teams working across autoinjectors, pen injectors, prefilled syringes, on-body/wearable injectors, infusion systems, and related delivery platforms.

This is a hands-on leadership role for someone who can set technical direction, develop engineers, strengthen laboratory execution, and serve as a credible technical partner to clients from early development through verification, validation, investigation, and design-history-file execution.

Job Duties

• Lead, develop, and hold accountable a team of approximately 12–15 engineers; build technical depth through coaching, feedback, mentoring, and clear performance expectations.
• Provide technical leadership and final engineering review for protocols, reports, investigations, deviations, test methods, design inputs, risk documentation, and other critical technical deliverables.
• Lead complex medical-device and combination-product programs, including test-method development and validation, design-input refinement, design verification and validation, failure investigation, and design-history-file support.
• Drive engineering excellence across the laboratory by improving technical capability, equipment readiness, documentation quality, throughput, right-first-time execution, and use of sound engineering and statistical methods.
• Partner with Quality and Operations to ensure equipment qualification, calibration, maintenance, laboratory readiness, and compliant execution are effectively planned and sustained.
• Serve as a senior technical interface with clients: translate ambiguous technical problems into practical development strategies, communicate risk and recommendations clearly, and guide teams toward sound technical decisions.
• Support growth of companies services by contributing to proposals, technical scoping, new-service development, client relationships, and thought leadership.
• Apply critical thinking, risk-based decision making, root-cause analysis, and data-driven problem solving to resolve technical issues and continuously improve engineering processes.
  
  

Requirements

• Bachelor’s degree in Engineering or a closely related technical discipline; advanced degree is a plus.
• Approximately 15 years of progressive medical-device / product-development experience, with substantial experience in drug-device combination products and injection systems.
• Proven leadership of engineering teams, including direct people management, technical coaching, resource prioritization, and performance accountability.
• Demonstrated success leading complex development, testing, verification/validation, or investigation programs in regulated environments.
• Strong working knowledge of design controls, DHF expectations, risk management, statistics, root-cause analysis, and applicable device / combination-product standards.
• Broad technical understanding of device design, materials, manufacturing processes, test equipment, laboratory methods, and failure mechanisms.
• Ability to communicate effectively with engineers, executives, Quality, Commercial teams, external partners, and clients.
• Recognized technical depth in one or more relevant areas and the judgment to challenge assumptions and guide sound engineering decisions.
  
  

Terms & Start

• Permanent Role
• Start ASAP
• 175-200k with bonus
• Onsite 4 days a week in Northbrook, IL
• Benefits included: Medical, Dental, Vision, 401k