manufacturing engineer

CMSAt ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world: 1. LifeVest, the world's first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death. 2. HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent. 3. TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. ZOLL has been Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and even one of Pittsburgh's Coolest Offices. But it's our unique opportunity to impact people's lives that makes ZOLL the ideal place to build your career. Job Type On Site Job Summary Develop, validate, document, maintain, and support processes, equipment, and process controls to assure that electro-mechanical products meet specifications and applicable regulations. Develop, implement, and manage value improvement projects which incorporate a Lean/Six-Sigma approach. Provide timely and effective development and implementation of manufacturing standards and process specifications to assure achievement of operations objectives. Implement production testing methods and procedures to assure that products meet specifications. Perform analyses on quality information to proactively improve potential problems and capture improvement opportunities. Essential Functions 1. Support new product development teams as manufacturing representative, ensuring a successful transfer of design into production. 2. Evaluate new product designs to influence Design for Manufacturability, Design for Serviceability and Design for Cost by providing feedback to R&D during early phases of projects. 3. Develop and improve process flows to ensure quality and production efficiency. 4. Develop work plans as inputs to project schedules. 5. Actively participate within a team to develop and improve the manufacturing processes for existing and new products. 6. Develop and maintain robust Master Validation Plans for manufacturing processes. 7. Create and execute IQ, OQ, PQ, TMV, Gage R&R protocols as required in the Master Validation Plan. 8. Lead cross-functional team to create Process Failure Modes and Effects Analysis as part of internal risk management program. 9. Lead implementation of sustaining changes at remote distribution and service facilities. 10. Work closely with Operations groups, suppliers, and Quality Assurance to resolve in-house and supplier quality problems using established problem-solving methodologies. 11. Support product transfers from outside vendors and other plants/facilities. 12. Identify and support cost reduction projects to achieve goals. 13. Define & implement specific solutions to technical problems, completing the tasks and writing reports that clearly document the results. 14. Review & approve inspection plans, routers and product drawings. 15. Identify sources of waste in production and implement changes that drive cost, quality and delivery. 16. Identify and implement ergonomic improvements. Requi ed/Preferred Education and Experience 1. Bachelor's Degree Manufacturing Engineering, Industrial engineering or a related discipline or equivalent required 2. 4+ years of Operations Engineering experience in a manufacturing environment required Knowledge, Skills and Abilities 1. Demonstrated experience with supporting projects and effectively communicating project status. 2. Experience with ISO quality systems and regulated manufacturing environments. 3. Demonstrated use of risk management and quality tools such as failure modes and effects analysis and control plans. 4. Ability to work as a team member within a cross-functional project team. 5. Demonstrated proficiency in Lean and problem-solving tools with a high focus on process improvement. 6. Experience in defining process requirements. 7. Computer skills using Microsoft Office applications (Excel, Outlook, Teams, Word, PowerPoint). Microsoft Project, Minitab, Solidworks. Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 1. Standing - Constantly 2. Walking - Constantly 3. Sitting - Occasionally 4. Lifting - Constantly 5. Carrying - Constantly 6. Pushing - Constantly 7. Pulling - Constantly 8. Talking - Occasionally 9. Hearing - Frequently 10. Repetitive Motions - Constantly 11. Eye/Hand/Foot Coordination - Constantly Working Conditions 1. Extreme cold - Occasionally 2. Extreme heat - Occasionally 3. Humidity - Occasionally 4. Wet - Occasionally 5. Noise - Frequently ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives. The annual salary for this position is: $90,000.00 to $108,000.00 Factors which may affect starting salary include geography,