Open Position: Director of Engineering (On-Site)
Function: Research & Development
Summary
EdgeOne Medical is seeking an experienced Director of Engineering to lead our on-site engineering team in Wheeling, Illinois. This role combines people leadership, technical authority, client engagement, and operational ownership.
Please send your resume and a cover letter to careers@edgeonemedical.com and include Director of Engineering in the Title.
Essential Duties and Responsibilities
- Lead, develop, and hold accountable a team of approximately 12–15 engineers, providing coaching, mentoring, feedback, and clear performance expectations.
- Partner with Quality and Operations to ensure equipment qualification, calibration, maintenance, laboratory readiness, and compliant execution are effectively planned and sustained.
- Provide technical leadership and final engineering review for protocols, reports, investigations, deviations, test methods, design inputs, risk documentation, and other critical technical deliverables.
- Serve as a senior technical interface with clients, translating technical challenges into practical development strategies and clearly communicating risks and recommendations.
- Lead complex medical-device and combination-product programs, including test-method development and validation, design-input refinement, design verification and validation, failure investigations, and DHF support.
- Set technical direction and strengthen engineering capabilities across combination-product development, testing, verification, validation, investigations, and technical consulting.
- Drive engineering excellence across the laboratory by improving technical capabilities, equipment readiness, documentation quality, throughput, and right-first-time execution.
- Support the growth of EdgeOne Medical services through 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.
- Lead engineering teams across drug-device combination-product platforms, including autoinjectors, pen injectors, prefilled syringes, on-body/wearable injectors, infusion systems, and related delivery platforms.
Qualifications
Candidates should bring substantial, hands-on experience with drug-device combination products and injection systems, preferably across multiple delivery platforms:
- Autoinjectors and safety systems
- Pen injectors and cartridge-based delivery systems
- Prefilled syringes and needle-based injection systems
- On-body / wearable injectors and electromechanical delivery systems
- Infusion or related subcutaneous drug-delivery platforms
Experience should include meaningful leadership across the product-development lifecycle, such as design controls, requirements and systems engineering, risk management, test-method development/validation, design verification, human-factors interfaces, design transfer, supplier/partner management, investigations, and technical documentation.
- 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.
- Recognize technical depth in one or more relevant areas and the judgment to challenge assumptions and guide sound engineering decisions.
- Experience in a consulting, contract-development, testing, or other service-based organization is strongly preferred.
- Ability and willingness to work on-site in Wheeling, Illinois.
Equal Employment Opportunity
Discrimination in hiring, promotion and all other employment decisions on the basis of race, color, religion, gender, national origin, age, disability, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other basis protected by Federal, state or local laws is prohibited.