Edwards Lifesciences
Senior Engineer, Cardiac Biosimulations, Clinical Development
Edwards Lifesciences, Irvine, California, United States, 92713
Overview
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is pursuing an innovative portfolio of technologies to address unmet clinical needs and improve patient lives. Join us and be part of our inspiring journey. Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Responsibilities
Applies knowledge of technical principles and Edwards systems/procedures to optimize product development. Lead in the improvement, design and optimization of more complex experiments, tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to clinical impact. Generate test methods, podium data, white papers, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications. Create/update more complex design control documents including requirement specs, and risk documents Develop and execute engineering project plans Proactively identify new solutions to clinical questions, achieve practical approaches to substantiate marketing claims. Evaluate input and form a technical recommendation including designing parts, components and subsystems Train, coach, and guide lower level employees on routine procedures What you\'ll need (Required):
Bachelor\'s Degree in Engineering or Scientific field, 4 years experience Required or Master\'s Degree or equivalent in Engineering or Scientific field, 3 years experience Required or Ph.D. or equivalent in Engineering or Scientific field Required What else we look for (Preferred):
Proven expertise in usage of MS Office Suite; CAD experience preferred Strong 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 required (if applicable) Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering Strong problem-solving, organizational, analytical and critical thinking skills Substantial understanding of processes and equipment used in assigned work Good leadership skills and ability to influence change Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing 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 inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations 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 Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $106,000 to $149,000(highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Applications will be accepted while this position is posted on our Careers website.
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Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is pursuing an innovative portfolio of technologies to address unmet clinical needs and improve patient lives. Join us and be part of our inspiring journey. Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease. Responsibilities
Applies knowledge of technical principles and Edwards systems/procedures to optimize product development. Lead in the improvement, design and optimization of more complex experiments, tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to clinical impact. Generate test methods, podium data, white papers, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications. Create/update more complex design control documents including requirement specs, and risk documents Develop and execute engineering project plans Proactively identify new solutions to clinical questions, achieve practical approaches to substantiate marketing claims. Evaluate input and form a technical recommendation including designing parts, components and subsystems Train, coach, and guide lower level employees on routine procedures What you\'ll need (Required):
Bachelor\'s Degree in Engineering or Scientific field, 4 years experience Required or Master\'s Degree or equivalent in Engineering or Scientific field, 3 years experience Required or Ph.D. or equivalent in Engineering or Scientific field Required What else we look for (Preferred):
Proven expertise in usage of MS Office Suite; CAD experience preferred Strong 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 required (if applicable) Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering Strong problem-solving, organizational, analytical and critical thinking skills Substantial understanding of processes and equipment used in assigned work Good leadership skills and ability to influence change Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing 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 inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations 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 Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California (CA), the base pay range for this position is $106,000 to $149,000(highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).Applications will be accepted while this position is posted on our Careers website.
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