2nd Shift Engineer II, Manufacturing
Type
Full time
Location
Job reference
Req-37741
Posted for
1 day ago
Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.
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. Join us and be part of our inspiring journey.
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 skills
- Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
- Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
- Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
- Establish 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 work
- Other incidental duties assigned by Leadership
What you'll need (Required):
- Bachelor's Degree in an Engineering or Scientific field with 2 years of previous related experience required or
- Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education required
What else we look for (Preferred):
- Experience working in the medical device and/or a regulated industry
- Good computer skills in usage of MS Office Suite including MS Project; CAD experience
- Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
- Basic understanding of statistical techniques
- Previous experience working with lab/industrial equipment
- Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Solid problem-solving, organizational, analytical and critical thinking skills
- Solid understanding of processes and equipment used in assigned work
- Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
- Knowledge of applicable FDA regulations for medical device industry
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
- Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
- Ability to build productive internal/external working relationships
- Adhere 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/control
Wichtiger Hinweis für Kandidaten
COVID-Impfvorschrift
Edwards hat sich verpflichtet, die Anforderungen und Richtlinien unserer Regierungsbehörden einzuhalten und unsere gefährdeten Patienten und die Gesundheitsdienstleister, die sie auf der ganzen Welt behandeln, zu schützen. Aus diesem Grund ist für alle Positionen im Gesundheitswesen eine COVID-19-Impfung erforderlich, d. h. für alle, die direkt mit Patienten zu tun haben, und für alle, die im Rahmen ihrer Tätigkeit mit Gesundheitsdienstleistern zu tun haben. Wenn Sie eingestellt werden, müssen Sie als Einstellungsvoraussetzung nachweisen, dass Sie vollständig gegen COVID-19 geimpft sind oder eine gültige religiöse oder medizinische Befreiung von der Impfung haben. Diese Impfpflicht gilt nicht in Ländern, in denen es gesetzlich verboten ist, eine Impfung vorzuschreiben. In Ländern, in denen weniger Impfstoffe zur Verfügung stehen oder andere Anforderungen bestehen, können wir alternative Maßnahmen ergreifen, die die Sicherheit der Patienten und des medizinischen Personals optimieren, z. B. regelmäßige COVID-Tests oder spezielle Maskierungsanforderungen.
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