Director of Engineering

The On-Site Engineering Leader provides technical and people leadership for the engineering function and is accountable for the quality, predictability, and growth of engineering delivery. This leader combines deep combination-product and medical-device expertise with hands-on direction of design controls, test method development and validation, device verification, investigations, and Design History File (DHF) documentation. Working on-site with Engineering, Quality, Project Management, Laboratory Operations, subject matter experts, and clients, this role builds strong technical standards, develops engineering talent, resolves complex issues, and aligns capacity and priorities to deliver compliant, on-time, and on-budget project work.

Key Accountabilities

• Lead the on-site engineering organization and establish clear expectations for technical rigor, ownership, responsiveness, documentation quality, and first-pass quality.
• Own the quality, completeness, and timeliness of engineering outputs, including development plans, design inputs and outputs, analyses, risk management deliverables, test strategies, methods, protocols, reports, investigations, and DHF documentation.
• Serve as the senior on-site technical authority for complex combination-product and medical-device decisions, design reviews, failure investigations, and cross-program technical escalations.
• Ensure engineering work complies with internal quality systems, client requirements, applicable cGMP and design-control expectations, ISO 13485, ISO 14971, and relevant FDA regulations and guidance.
• Provide technical direction for test method development, feasibility studies, characterization, method validation, device verification, complaint testing, and related laboratory execution.
• Ensure protocols and acceptance criteria are technically sound, risk-based, executable, and aligned across Engineering, Quality, Project Management, and Laboratory Operations before testing begins.
• Lead structured problem solving and root cause analysis for technical failures, nonconformances, out-of-specification results, deviations, and client concerns, ensuring conclusions and corrective actions are evidence-based and defensible.
• Partner with Quality to maintain audit-ready engineering records, strengthen investigation discipline, support CAPAs and audits, and prevent recurrence through effective systemic actions.
• Own engineering capacity planning and resource alignment with Project Management and functional leaders, balancing portfolio priorities, capability needs, utilization targets, employee development, and sustainable workloads.
• Monitor project health and intervene early when technical risk, scope ambiguity, resource constraints, rework, or decision delays threaten schedule, budget, quality, or client commitments.
• Coach and develop engineering staff through clear goals, regular feedback, technical mentoring, development plans, and performance management.
• Build the engineering talent pipeline by defining role expectations, supporting technical career progression, identifying succession needs, and leading hiring and onboarding efforts.
• Partner with Project Management to clarify scope, assumptions, deliverables, dependencies, and change impacts while communicating technical status and risks effectively to clients.
• Support Business Development and proposal efforts with technical scoping, effort estimates, risk assessments, solution design, and participation in client discussions when senior technical leadership is required.
• Standardize engineering templates, review practices, design and testing approaches, and reusable knowledge while expanding the practical use of established methodologies where appropriate.
• Lead continuous improvement initiatives using data, standard work, lean methodologies, and Kaizen principles to reduce rework, shorten review and investigation cycle times, and improve execution predictability.
• Establish and review engineering performance metrics, including on-time delivery, first-pass quality, rework trends, investigation cycle time, utilization, budget performance, and staffing or capability gaps.
• Escalate significant technical, compliance, resource, or delivery risks to executive leadership with clear facts, business impact, options, and recommended actions.

Preferred Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Systems Engineering, Materials Engineering, Manufacturing Engineering, or a related discipline. Advanced degree preferred.
• 10+ years of progressive engineering experience within medical devices, combination products, drug-delivery systems, or a similarly regulated industry, including demonstrated technical leadership responsibility.
• Experience leading engineers and multidisciplinary technical teams in a client‑facing consulting, product development, testing, or contract services environment.
• Strong combination-product experience involving delivery platforms such as autoinjectors, pen injectors, prefilled syringes, on‑body injectors, inhalation devices, vial kits, or other drug–device systems.
• Deep knowledge of design controls, risk management, design verification and validation, requirements traceability, DHF documentation, and regulated product‑development processes.
• Hands‑on experience with test method development, validation, characterization, device verification, protocol and report authoring, and technical review of laboratory data.
• Experience leading technical investigations and root cause analyses related to product failures, nonconformances, deviations, complaints, or out‑of‑specification results.
• Working knowledge of FDA regulations and guidance, cGMP requirements, ISO 13485, ISO 14971, human factors engineering, and relevant device or combination‑product standards.
• Demonstrated ability to translate client and regulatory requirements into technical strategies, executable plans, defensible acceptance criteria, and high‑quality deliverables.
• Experience in capacity planning, portfolio prioritization, resource allocation, and utilization management.
• Proven success developing engineering talent through coaching, feedback, technical reviews, career development, and performance management.
• Excellent written and verbal communication skills with the ability to communicate complex technical concepts to clients, executives, quality organizations, and cross‑functional teams.
• Experience with Lean Manufacturing, Kaizen, standard work, visual management, or other continuous improvement methodologies preferred.