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.