Engineer II, Manufacturing

Edwards Lifesciences Gruppe; Salt Lake City (UT); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Edwards Lifesciences is seeking an Engineer II to support THV delivery systems manufacturing. You will drive continuous improvement, apply Six Sigma and LEAN methods, and work with Quality, Operations, and NPD to resolve day-to-day manufacturing challenges.

The role emphasizes process optimization, documentation, and cross-functional collaboration to ensure product quality and regulatory compliance in a fast-paced environment.

Qualifikationen

• Bachelor's degree in Engineering or Scientific field with 2 years of related experience.
• Master's degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education
• Lean Six Sigma certification preferred.
• Experience in the medical device industry or another highly regulated manufacturing environment preferred.
• Experience with Root Cause Analysis (RCA), Nonconformance Reports (NCRs), and CAPAs.
• Good computer skills in MS Office Suite including MS Project; CAD experience.

Aufgaben

• Optimize manufacturing processes, including using Six Sigma and LEAN methods for continuous process improvement or redesign of equipment, tools, fixtures.
• Use Root Cause analysis tools to solve moderately complex process issues.
• Develop moderately complex experiments and tests to qualify and validate manufacturing processes; analyze results and develop reports.
• Troubleshoot simple mechanical systems and diagnose in-line equipment issues.
• Develop training and documentation materials for production to enable knowledge transfer.
• Establish project plans to ensure deliverables meet customer expectations using project management tools.
• Oversee manufacturing support tasks; coordinate technicians and vendors; work with cross-functional groups to solve problems.

Jobbeschreibung

Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives.This Engineer II will play a key role in supporting and sustaining the manufacture of THV delivery systems while driving continuous improvement initiatives across the production environment. In collaboration with cross-functional partners, they will identify opportunities to enhance manufacturing processes, improve product quality and reliability, and increase operational efficiency to support business and patient needs.How you'll make an impact:Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skillsUse Root Cause analysis tools to solve moderately complex process issuesDevelop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reportsTroubleshoot simple mechanical systems, and ability to diagnose in-line equipment issues if they ariseAnalyze and resolve moderately complex Compliance issues (e.g., CAPA, non-conformances, audit observationsDevelop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processesEstablish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician workPartner with cross-functional groups like Quality, Complaints, Operations and NPD to solve day to day manufacturing problemsOther incidental duties assigned by LeadershipWhat you'll need (Required):Bachelor's Degree in Engineering or Scientific field with 2 years of related experience ORMaster's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/educationWhat else we look for (Preferred):Lean Six Sigma certificationPMP certificationExperience working in the medical device industry or another highly regulated manufacturing environmentExperience with Root Cause Analysis (RCA), Nonconformance Reports (NCRs), and Corrective and Preventive Actions (CAPAs)Good computer skills in usage of MS Office Suite including MS Project; CAD experienceGood documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skillsBasic understanding of statistical techniquesSolid understanding and knowledge of principles, theories, and concepts relevant to EngineeringSolid problem-solving, organizational, analytical and critical thinking skillsSolid understanding of processes and equipment used in assigned workStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentMust be able to work in a team environment, including the ability to manage vendors and project stakeholdersAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.