2nd Shift Engineer II, Manufacturing

2nd Shift Engineer II, Manufacturing Edwards Lifesciences - 3.9 Salt Lake City, UT Job Details Full-time 7 hours ago Qualifications Industrial equipment design Environmental regulations Statistics Performance improvement leadership Project engineering Safety protocol adherence Team leadership Technical documentation Safety regulations Design of manufacturing processes Engineering Tooling design Technical writing within manufacturing CAD design (engineering design task) Vendor coordination Six Sigma methodology implementation Engineering process optimization Corrective and preventive actions (CAPA) Cleanroom protocols Training material drafting Mid-level Project management in manufacturing Statistical analysis Analysis skills Bachelor's degree in engineering Production validation processes Quality risk management Medical device manufacturing facility experience Task prioritization Scientific protocols Full Job Description 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. 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 Engineering or Scientific field with 2 years experience OR Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education What else we look for (Preferred): Experience working in a regulated industry, medical device preferred 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 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 E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require

COVID-19

vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.