Job Description

Locations

• USA - California – Irvine

Salary

Skills Required

• usage of MS Office Suiteintermediate
• principlesintermediate
• and adherence to Edwards Environmental Healthintermediate

Required Qualifications

• Bachelor's Degree in Engineering or Scientific field with 4 years of experience -OR- Master's Degree or equivalent in Engineering or Scientific field with 3 years of experience -OR- Ph.D. or equivalent in Engineering or Scientific field (experience, 4 years)
• Hands-on experience within the medical device industry (experience)
• Bachelor's Degree in Engineering or Scientific field with 4 years of experience -OR- Master's Degree or equivalent in Engineering or Scientific field with 3 years of experience -OR- Ph.D. or equivalent in Engineering or Scientific field (experience, 4 years)
• Hands-on experience within the medical device industry (experience)

Preferred Qualifications

• Direct experience working with Class III devices strongly preferred (experience)
• Proven expertise in usage of MS Office Suite; CAD experience preferred (experience)
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills (experience)
• Basic understanding of statistical techniques (experience)
• Previous experience working with lab/industrial equipment (experience)
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering (experience)
• Strong problem-solving, organizational, analytical and critical thinking skills (experience)
• Substantial understanding of processes and equipment used in assigned work (experience)
• Good leadership skills and ability to influence change (experience)
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing (experience)
• Strict attention to detail (experience)
• Ability to interact professionally with all organizational levels (experience)
• Ability to manage competing priorities in a fast paced environment (experience)
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects (experience)
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations (experience)
• 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 (experience)
• Direct experience working with Class III devices strongly preferred (experience)
• Proven expertise in usage of MS Office Suite; CAD experience preferred (experience)
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills (experience)
• Basic understanding of statistical techniques (experience)
• Previous experience working with lab/industrial equipment (experience)
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering (experience)
• Strong problem-solving, organizational, analytical and critical thinking skills (experience)
• Substantial understanding of processes and equipment used in assigned work (experience)
• Good leadership skills and ability to influence change (experience)
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing (experience)
• Strict attention to detail (experience)
• Ability to interact professionally with all organizational levels (experience)
• Ability to manage competing priorities in a fast paced environment (experience)
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects (experience)
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations (experience)
• 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 (experience)
• 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 $108,000 to $153,000 (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. (experience)

Responsibilities

• Create, test, and/or improve products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
• Define unmet needs through literature reviews or high-touch engagements such as voice of customer (VOC) with Health Care Practitioners (HCPs)
• Participate with cross functional teams through complex design activities including requirements identification, boundary condition definition, and test method and model development & validations
• Ideate and generate novel concepts and incept first designs and prototypes
• Perform early concept development by utilizing predictive engineering methods and tools (e.g. FEA, DOE) and collaborating with enabling technology R&D teams
• Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications
• Develop and execute engineering project plans
• Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
• Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• Evaluate input and form a technical recommendation including designing parts, components and subsystems
• Train, coach, and guide lower level employees on routine procedures
• Travel domestically and internationally to congress and society meetings, HCP and internal events, and to observe therapies (up to 10%)
• Other duties assigned by Leadership
• Create, test, and/or improve products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles
• Define unmet needs through literature reviews or high-touch engagements such as voice of customer (VOC) with Health Care Practitioners (HCPs)
• Participate with cross functional teams through complex design activities including requirements identification, boundary condition definition, and test method and model development & validations
• Ideate and generate novel concepts and incept first designs and prototypes
• Perform early concept development by utilizing predictive engineering methods and tools (e.g. FEA, DOE) and collaborating with enabling technology R&D teams
• Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications
• Develop and execute engineering project plans
• Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
• Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• Evaluate input and form a technical recommendation including designing parts, components and subsystems
• Train, coach, and guide lower level employees on routine procedures
• Travel domestically and internationally to congress and society meetings, HCP and internal events, and to observe therapies (up to 10%)

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