Director of Engineering

Director Of Engineering

The Director of Engineering leads technical capabilities across product life cycles to drive profitable growth, commercialize complex medical device programs, improve manufacturing performance, and deliver differentiated end-of-line solutions, including assembly, cleaning, packaging, labeling, and sterilization management, while translating business strategy into priorities, investments, talent plans, and measurable quality, delivery, cost, compliance, and customer outcomes.

Responsibilities include leading technical business development to achieve revenue, margin, and strategic growth objectives by partnering across Sales, Marketing, Operations, Quality, and Finance to qualify and pursue opportunities aligned with company capabilities. The Director of Engineering will translate customer needs into differentiated, manufacturable, and commercially viable solutions through credible technical engagement with prospective and existing customers.

Other responsibilities include owning technical proposals, feasibility assessments, manufacturing concepts, capital and risk requirements, cost models, and launch strategies to improve pipeline quality and opportunity conversion. The Director of Engineering will build customer confidence and expand existing accounts by clearly communicating capabilities, risks, tradeoffs, and implementation plans across end-of-line and other value-added services.

In partnership with the VP of Technology, the Director of Engineering will develop and execute a scalable, compliant, and cost-effective roadmap for medical device end-of-line capabilities, including technology selection, process development, equipment and controls strategy, testing, inspection, validation, and documentation across manual, semi-automated, and automated processes.

The Director of Engineering will integrate end-of-line requirements early in opportunity qualification and new product introduction to reduce risk, accelerate commercialization, and meet customer and business requirements. The Director of Engineering will lead successful commercialization of new medical device programs from feasibility through validated production and transfer to operations, ensuring manufacturability, end-of-line requirements, technical deliverables, risk controls, resources, and launch-readiness criteria are addressed early.

The Director of Engineering will drive disciplined launch execution by resolving and escalating technical issues, ensuring processes and documentation are complete and capable, and using post-launch reviews to reduce delays, cost, instability, technical escapes, and corrective work.

The Director of Engineering will provide leadership for process validation, packaging validation, cleaning validation, sterilization validation management, equipment qualification, and verification activities within the position's scope. The Director of Engineering will partner with Operations and Quality to resolve complex manufacturing problems and implement sustainable corrective and preventive solutions.

The Director of Engineering will standardize and continuously improve engineering practices across programs, processes, and facilities where appropriate. The Director of Engineering will support customer and regulatory audits as the senior technical representative for applicable engineering and end-of-line processes.

The Director of Engineering will maintain current knowledge of medical device manufacturing standards, regulatory expectations, and relevant end-of-line technologies. The Director of Engineering will build an accountable, customer-focused, and commercially oriented engineering organization capable of supporting growth and operational performance.

The Director of Engineering will translate business strategy into engineering priorities, annual objectives, staffing plans, capability-development plans, budgets, and measurable results. The Director of Engineering will develop engineering leaders and technical talent through clear expectations, coaching, succession planning, targeted development, and performance accountability.

The Director of Engineering will ensure engineering resources are aligned with the highest-priority growth, launch, customer, compliance, and operational needs. The Director of Engineering will establish appropriate technical governance, design reviews, program reviews, and escalation practices.

The Director of Engineering will promote collaboration across Sales, Marketing, Operations, Quality, Supply Chain, Customer Service, and Finance. The Director of Engineering will create a culture of disciplined execution, continuous improvement, technical curiosity, urgency, and follow-through.