Methuen, MA, 01844, USA
27 days ago
Senior Continuous Improvement Engineer
At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. **Position Summary:** The Continuous Improvement Engineer will spearhead process optimization, efficiency enhancement, and operational excellence within an electro-mechanical manufacturing environment for medical devices. In this high-visibility role, you will focus on identifying, analyzing, and implementing initiatives that meet or exceed ISO 13485 standards, ensuring exceptional product quality, cost-effectiveness, and regulatory compliance. Working closely with the Site Leadership and Product teams, you will drive transformative improvements through Kaizen initiatives, helping to elevate the performance of the Methuen site. **Essential Functions:** + Lead and support continuous improvement initiatives aimed at enhancing product quality, improving site safety standards, boosting operational efficiency, and minimizing waste by applying Lean and Six Sigma principles. + Conduct value stream analyses for all INR operations, identifying opportunities for efficiency, cost reduction, and quality improvement. + Plan, organize, and manage continuous improvement projects, working with sustaining manufacturing engineering and cross-functional stakeholders for timely execution. + Implement best practices in electro-mechanical manufacturing to meet ISO 13485 requirements, ensuring compliance with medical device regulatory standards. + Develop technical product knowledge across all INR-manufactured products and create a plan to achieve working expertise. + Effectively manage the continuous improvement portfolio, proactively updating leadership on project progress. + Participate in internal audits, CAPA processes, and root cause analysis to ensure regulatory compliance. + Maintain comprehensive documentation to support regulatory audits and inspections. **Cross-functional Collaboration:** + Partner with Engineering, Quality, Production, and Supply chain teams to align continuous improvement initiatives with organizational goals. + Serve as the key liaison between the production floor and management, fostering a culture of continuous improvement across all departments. **Data Analysis & Reporting:** + Collect and analyze production data to monitor KPIs, identify trends, and recommend process adjustments to improve yield, reduce downtime, and enhance overall performance. + Prepare detailed reports on process improvements, highlighting their impact on operational metrics such as cost savings, cycle time reductions, and product quality enhancements. **Training & Leadership:** + Develop and deliver training programs to promote Lean methodologies, Six Sigma, and continuous improvement strategies across teams. + Lead cross-functional teams in Kaizen events, process improvement workshops, and problem-solving initiatives. **Qualifications:** + Bachelor’s degree in industrial engineering, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or a related field. Advanced degrees or certifications (e.g., master’s in engineering, MBA, Six Sigma Black Belt) are preferred. + A minimum of 8 years of experience in an engineering environment, ideally within the medical device or aviation industries, focusing on complex electro-mechanical products in regulated environments. + At least 3 years of experience implementing continuous improvement initiatives, with successful completion of at least one full-scale factory transformation project. + Solid understanding of Lean Manufacturing principles, Six Sigma methodology, and other operational excellence frameworks (e.g., TPM, BPM, DBS). + Experience leading Kaizen events and Continuous Improvement workshops. + Familiarity with ISO 13485-regulated environments is advantageous. + Preferably, experience in regulated capital equipment industries such as aviation, automotive, or semiconductor. + Strong problem-solving and analytical abilities, with expertise in applying statistical tools and advanced root cause analysis. + Extensive knowledge of capital equipment manufacturing processes, with a particular focus on electro-mechanical assembly and site safety standards. + Excellent project management skills, with a solid grasp of risk management and mitigation strategies. + Exceptional communication and leadership skills, with a proven ability to influence and drive change across cross-functional teams. + Experience conducting internal audits and ensuring regulatory compliance. + Proficiency in Microsoft Office and advanced knowledge of manufacturing software, including ERP systems. + Six Sigma Green Belt or Black Belt certification (preferred) or equivalent. + Lean Manufacturing Certification or equivalent. + Occasional travel (<15%), including some overnight stays. **Physical Demands** **:** The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job. + Required to sit; climb or balance; and stoop, kneel, crouch or crawl + Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds + Required to possess specific visons abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus **Our Values** **:** Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven. + **Passionate about Innovation** : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions. + **Customer Focused** : We listen to our customers’ needs and respond with a sense of urgency. + **Teamwork** : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger. + **Driven** : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients. **Equal Employment Opportunity** **:** Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful. **Other Duties** **:** Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. **Our Values** **:** Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven. + **Passionate about Innovation** : Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions. + **Customer Focused** : We listen to our customers’ needs and respond with a sense of urgency. + **Teamwork** : Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger. + **Driven** : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients. **Equal Employment Opportunity** **:** Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful. **Other Duties** **:** Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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