Manufacturing Engineer
Sendx Medical, Inc.
Manufacturing EngineerAre you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.The Manufacturing Engineer is responsible for providing daily engineering support to Manufacturing Operations while driving continuous improvement initiatives that enhance safety, quality, productivity, and cost performance. This role serves as a key technical resource for manufacturing processes, ensuring consistent product quality, operational efficiency, and regulatory compliance.The Manufacturing Engineer will lead efforts to optimize manufacturing processes by reducing process variation, improving process capability, minimizing waste, and increasing overall equipment and operational effectiveness. Through data-driven analysis and problem-solving, this position will identify and implement sustainable improvements that reduce defects, improve customer satisfaction, and support the achievement of site performance objectives.This role requires close collaboration with cross-functional teams, including Quality, Operations, Maintenance, Facilities, Environmental Health & Safety, Product Engineering, Advanced Engineering, and Research & Development (R&D). Key responsibilities include supporting customer complaint investigations and corrective actions, facilitating the introduction of new products, processes, and equipment, supporting validation and qualification activities, and driving improvements in equipment reliability, maintenance strategies, and manufacturing performance.The successful candidate will combine strong technical expertise, analytical problem-solving skills, and project leadership capabilities to deliver measurable improvements in product quality, process reliability, operational efficiency, and overall business performance. This position reports to the Sr Facilities, Maintenance, and Engineering Manager and is part of Manufacturing & Operations located in Hauppauge, NY and will be an on-site role.What you will do:Develop deep expertise in manufacturing processes and serve as a technical subject matter expert to support Operations, Maintenance, Quality, and Customer needs.Lead root cause investigations, identify systemic issues, and implement effective Corrective and Preventive Actions (CAPAs) to resolve manufacturing, equipment, and quality challenges.Analyze process performance and design, develop, validate, and implement process improvements to achieve site goals related to safety, product quality, productivity, capacity, and cost reduction.Partner with cross-functional teams including Quality, Operations, Maintenance, Supply Chain, and R&D to support change management and equipment, process, and product Qualification and Validation activities.Provide technical leadership and hands-on support during troubleshooting, process optimization, and continuous improvement projects.Who you are:Bachelor's degree in Mechanical, Electrical, Industrial, Manufacturing Engineering, or a related technical discipline, with a minimum of 5 years of engineering experience in a manufacturing environment.Demonstrated ownership of production processes and continuous improvement initiatives, with the ability to develop strong process knowledge and serve as a technical resource for manufacturing operations.Strong technical aptitude and structured problem-solving skills, including the ability to analyze complex manufacturing challenges, lead root cause investigations, implement CAPAs, and deliver effective, sustainable solutions.Proven ability to use data and metrics to drive decision-making, improve process performance, reduce variation, and sustain operational improvements aligned to safety, quality, productivity, capacity, and cost goals.Self-motivated and results-oriented, with strong interpersonal, written, and verbal communication skills; able to manage multiple priorities, execute with urgency, work independently, and collaborate effectively across Operations, Maintenance, Quality, and Engineering teams.Preferred Qualifications:Application of Lean Manufacturing, Six Sigma, Kaizen, 5S, and other continuous improvement methodologies to improve manufacturing performance.Strong knowledge of Root Cause Analysis, structured problem-solving techniques, CAPA processes, and data-driven decision-making methods, including statistical analysis, Statistical Process Control (SPC), and process capability analysis.Experience supporting Change Control, Risk Assessment, Process Validation, Equipment Qualification, and validation lifecycle activities within regulated manufacturing environments, including ISO 9001 and/or cGMP quality systems.Strong mechanical aptitude with experience troubleshooting manufacturing equipment, improving equipment reliability, and supporting process optimization efforts.Basic understanding of automation, control systems, sensors, PLCs, and production equipment, with experience partnering across Operations, Maintenance, and Quality to improve safety, quality, productivity, and overall manufacturing performance.
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