Director of Engineering

IntePros is currently looking for a Director of Engineering to join one of our growing Medical Device/Manufacturing clients in Philadelphia, PA. The Director of Engineering will lead the engineering team at our CDMO manufacturing site, overseeing all aspects of process engineering, project engineering, capacity management and capital management. This role requires a strategic leader with an understanding of Pharmaceutical and medical device regulations, a passion for continuous improvement and a commitment to quality and efficiency. Director of Engineering Responsibilities: Leadership & Strategy: Develop and implement engineering strategies aligned with global engineering and the company goals. Lead, mentor, and develop a high-performing engineering team. Foster a culture of innovation, collaboration, and continuous improvement. Work closely with Operations, Quality, EH&S and Sales and Project Management to ensure internal and external clients' requirements are met. Process Development and Validation: Work with OEM's and oversee the process development, and validation of new automation equipment. Ensure compliance with regulatory requirements (e.g., FDA, ISO 13485). Collaborate with Operations and Quality to validate and run automation equipment for our customers. Site Engineering: Lead the facilities team for any building modifications and improvements. Optimize manufacturing processes to improve efficiency, quality, and cost-effectiveness. Implement lean and continuous improvement methodologies. Quality & Compliance: Ensure all engineering activities comply with regulatory standards and company policies. Lead root cause analysis and corrective actions for product and process issues. Project and Capital Management: Manage multiple engineering projects, ensuring timely and successful completion. Develop and manage capital budgets, timelines, and resource allocation. Communicate project status and risks to senior management. Work with sales/marketing when estimating cost, resources and timing of new programs or changes to existing programs. Director of Engineering Qualifications: Required: Bachelor's Degree in engineering or a related field and 10-15 years related experience and/or training. Statistical and Advanced Mathematical Skills Familiar with lean, CI and six sigma Hands on engineering leader Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines Full Professional Proficiency: Ability to speak, read, write and present fluently and accurately on all levels pertinent to professional needs. Ability to show success in managing employees. Location requirement: Philadelphia, PA Some travel will be required ~5% Preferred: Master's Degree (M.A.) in related field. Pharmaceutical, Medical Device or Life Science experience Ability to set and achieve challenging goals. Lean & Six Sigma Certifications #LI-KS1

Created: 2025-03-10