Job Title

Key Areas of Responsibility Build and develop highly competent teams capable of executing the strategic plan, with deep technical skills, innovation ability, engineering expertise, and core competencies. Strengthen the organization’s manufacturing and process engineering capabilities through strategic hiring, training, and development of engineering talent. Deliver effective engineering solutions by leveraging methodologies such as Corrective and Preventive Action (CAPA), Statistical Process Control (SPC), Validation, Six Sigma, and other tools, ensuring full compliance with FDA QSR, ISO 13485, and Corporate/Divisional procedures. Develop and own a long-term engineering strategic plan (e.g., 5-year roadmap), refine and execute the technology strategy, and optimize manufacturing processes to drive cost reductions and quality improvements. May lead technical organizations across multiple locations. Partner with multi-divisional Advanced Operations (AO) teams to provide support and leadership during DR8–DR10 stages and execute successful product transfers. Ensure new products are designed and optimized for manufacturability, with complete validations and process documentation in place prior to production launch. Collaborate with cross-functional AO/NPD teams to drive a closed-loop system of technology and process improvement. Partner with Supplier Quality, AO, Supply Chain, and Strategic Sourcing teams to build strategic relationships with OEMs, component suppliers, and technology partners to ensure optimal vendor selection, pricing, and supply chain design. Oversee the specification, purchase, and qualification of capital equipment, ensuring sound engineering principles, design intent, and ROI. Provide effective support for daily production operations with a strong sense of urgency. Ensure products meet all performance, quality, cost, yield, and capacity requirements. Develop and deliver training and support materials as needed. Model and lead the integration of LEAN/Continuous Improvement (CI) principles. Implement a manufacturing strategy incorporating lean product development, lean manufacturing, and process/product flow optimization. Develop strong partnerships with leadership and foster a collaborative culture across cross-functional and multi-divisional teams, including AO, Production, HR, Quality, Facilities, Supply Chain, and Finance. Promote and drive a culture of safety and environmental excellence. Lead initiatives around workplace ergonomics and facility layout design. Ensure excellence in project management by providing weekly updates to senior leadership and stakeholders, and delivering all project commitments on time. Monitor and ensure adherence to monthly departmental and project budgets. Manage capital and expense forecasts and reporting. Maintain periodic contact with customers through in-person meetings, calls, written correspondence, and emails. Ensure department compliance with all company policies and corrective actions. Maintain required training related to department procedures. Use strong problem-solving skills to manage time and resources effectively. Continuously identify opportunities for improvement to enhance product quality and process performance. Qualifications (Education, Certifications, and/or Experience) Must be fully bilingual (English and Spanish). Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, Chemical, or Industrial). 10+ years of experience in engineering or a technical function. 8+ years of management experience. 3+ years of project management experience. Proven experience leading multidisciplinary engineering teams. Strong analytical and interpersonal communication skills. Demonstrated expertise in mechanical, electrical, or general engineering problem-solving. In-depth knowledge of industry standards, preferably in medical device manufacturing. Proven ability to lead and facilitate problem-solving teams. Experience developing detailed process plans using tools such as PFMEA, Fault Tree Analysis, and Safety & Efficacy reviews. Demonstrated ability to implement validated processes using tools such as Process Validation, DOE, and Process Planning. Skilled in applying Design for Manufacturability principles. Proficient in project planning and tracking tools (Gantt Charts, PERT Charts, etc.). Experience with capital equipment procurement and implementation. Strong cross-functional leadership and facilitation skills. Proven supervisory and managerial capabilities. Basic computer skills (e.g., Word processing, spreadsheets, databases). Project management and leadership training preferred. Ability to create and present detailed proposals, guidelines, and procedures. Capable of independently resolving complex process or system issues. Able to make operational decisions with division-wide implications. Ability to manage and prioritize multiple concurrent tasks. Physical/Mental Requirements Must be able to stand, walk, and sit for extended periods. Use hands for handling and feeling objects, reach with arms, balance, stoop, kneel, crouch, and communicate effectively. May occasionally lift or move items up to 50 pounds (seek assistance for heavier loads). Visual requirements include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. May be exposed to varying weather conditions and moderate noise levels. Potential exposure to hazardous materials, used medical devices, and cleaning agents; use of personal protective equipment (PPE) as required. Must consult Material Safety Data Sheets (MSDS) as applicable. May operate small hand tools, inspection equipment, and standard office equipment. Required to work in a fast-paced environment; may include extended work hours. Subject to changes in procedures and work environment. #J-18808-Ljbffr