Director of Engineering

Director of Engineering Ideal Candidate Profile

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.

• ◆Lead 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.
• ◆Translate customer needs into differentiated, manufacturable, and commercially viable solutions through credible technical engagement with prospective and existing customers.
• ◆Own technical proposals, feasibility assessments, manufacturing concepts, capital and risk requirements, cost models, and launch strategies to improve pipeline quality and opportunity conversion.
• ◆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, 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.
• ◆Integrate end-of-line

early in opportunity qualification and new product introduction to reduce risk, accelerate commercialization, and meet customer and business requirements.

• ✓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.
• ✓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.
• ✓Provide leadership for process validation, packaging validation, cleaning validation, sterilization validation management, equipment qualification, and verification activities within the position’s scope.
• ✓Partner with Operations and Quality to resolve complex manufacturing problems and implement sustainable corrective and preventive solutions.
• ✓Standardize and continuously improve engineering practices across programs, processes, and facilities where appropriate.
• ✓Support customer and regulatory audits as the senior technical representative for applicable engineering and end-of-line processes.
• ✓Maintain current knowledge of medical device manufacturing standards, regulatory expectations, and relevant end-of-line technologies.
• ✓Build an accountable, customer-focused, and commercially oriented engineering organization capable of supporting growth and operational performance.
• ✓Translate business strategy into engineering priorities, annual objectives, staffing plans, capability-development plans, budgets, and measurable results.
• ✓Develop engineering leaders and technical talent through clear expectations, coaching, succession planning, targeted development, and performance accountability.
• ✓Ensure engineering resources are aligned with the highest-priority growth, launch, customer, compliance, and operational needs.
• ✓Establish appropriate technical governance, design reviews, program reviews, and escalation practices.
• ✓Promote collaboration across Sales, Marketing, Operations, Quality, Supply Chain, Customer Service, and Finance.
• ✓Create a culture of disciplined execution, continuous improvement, technical curiosity, urgency, and follow-through.

Minimum Requirements, Education & Experience (incl. KSA’s and certifications)

• ✓Bachelor’s degree in engineering or a closely related technical field.
• ✓Ten or more years of progressive engineering, product-development, manufacturing, or technical operations experience.
• ✓Five or more years of leadership experience, including responsibility for technical teams, engineering leaders, budgets, priorities, and organizational performance.
• ✓Significant experience in medical device contract manufacturing, medical device operations, or a closely related regulated manufacturing environment.
• ✓Direct experience developing, commercializing, managing, or overseeing medical device end-of-line capabilities, including multiple areas such as assembly, cleaning, packaging, labeling, and sterilization management.
• ✓Demonstrated experience leading complex medical device programs from technical feasibility through process development, validation, launch, and transfer to routine production.
• ✓Proven track record of supporting profitable growth through technical business development, including customer engagement, opportunity qualification, solution development, technical proposals, cost modeling, estimating, and conversion of opportunities into new or expanded business.
• ✓Working knowledge of medical device Quality Management Systems, including ISO 13485, risk management, process validation, change control, and applicable regulatory requirements.
• ✓Busines