Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our EHS Engineering position is a unique career opportunity that could be your next step towards an exciting future. The EHS Engineer will support and Develop EHS site programmes, maintain EHS compliance and employee health. How you'll make an impact: R esponsible for developing, implementing, and maintaining environmental, health, and safety programs to ensure compliance with regulatory requirements and company standar ds. Collaborate with cross-functional teams to develop and implement processes to ensure compliance with EHS goals and programs. Provide EHS expertise for new processes, new products, and technologies and participate in the change control process of the site. Conduct risk assessments and job safety analysis relevant to the site needs. Compile, analyse, and evaluate EHS data relevant to the site needs. Conduct incident investigations, root cause analysis tools and identification of controls and prevention of reoccurrence. Develop and revise EHS training and written programs to ensure compliance with all applicable EHS regulations; may deliver training as necessary. Support maintenance of ISO 14001 and ISO 45001 Management System Certification. Conduct periodic internal inspections and audit s to ensure continuous compliance with applicable regulations; and provide guidance to appropriate team members. Other duties as assigned by management. What you'll need (Required) : Minimum Bachelors degree in a relevant Scientific/ Engineering Field plus at least 2 years industry experience in a similar role. What else we look for (Preferred): Good computer skills in usage of MS Office Suite Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills Solid understanding and knowledge of EPA, HSA, local regulations 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 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 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
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. The Receiving Inspector assesses components and devices upon receipt to ensure regulatory and company guidelines have been met, and that the components and devices meet operational standards as designed. Working Hours: 4 Evenings per week (Monday to Wed 4pm-2:30am, Thurs 4pm-1:30am) Key Responsibilities: Perform visual, dimensional, and functional inspection of components and devices using a wide variety of applicable instruments and equipment such as magnifying lamp, microscope, vision inspection system, calipers, etc. to ensure conformance with design specifications, working at a level greater independence with a higher level of productivity Perform verification of receiving documents with component and device drawings to ensure requirements are met Review, follow and perform job functions in compliance with established work instructions (i.e., routers) and adherence with SOPs, including recording traceable information on device history records and entering information into JDE. Control inventory to ensure appropriate storage conditions and movement, as well as ensuring correct labeling of product status. Train colleagues from other sites, including inspection of their work output Other incidental duties: General work area housekeeping, attend training for new processes and procedures Education and Experience: H.S. Diploma or equivalent Preferred 2 years experience previous related experience Required Previous medical device assembly experience Additional Skills: Full understanding of applicable inspection procedures Ability to continuously expands proficiency in inspection techniques Ability to use applicable instruments and equipment, hand eye coordination, and high manual dexterity Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System) Ability to effectively provide and accept feedback from colleagues on independent data verification Ability to provide feedback on product defects and follow through to establish resolution Good communication skills Strong English language skills, including reading, comprehending, speaking and writing, and strong communication skills Proficient computer skills, including strong working knowledge of manufacturing software Strict attention to detail Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Must be able to work with minimum supervision Work in a Team environment 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 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Manufacturing Engineer position is a unique career opportunity that could be your next step towards an exciting future. Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes. The Senior Manufacturing Engineer applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes. How you'll make an impact: Support process optimization initiative for delivery systems release testing, including design and implementation of in-process monitoring controls using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc. are up to standards Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyse results, make recommendations, and develop reports Resolve complex manufacturing and compliance issues related to process changes, RA submissions, and regulatory requirements Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes Lead and establish project plans to ensure deliverables are completed to customer's expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.) What you'll need (Required): Bachelor's degree in an Engineering or Scientific field plus at least 4 years of Industry experience Certifications in Six Sigma or Lean Black belt preferrable What else we look for (Preferred): Proven expertise in usage of MS Office Suite including MS Project Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills Strong understanding of statistical techniques Demonstrated application of DMAIC methodology in process improvement projects 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 Expertise in process validation, equipment qualification, and lean manufacturing 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 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 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
The patients we serve are at the heart of Edwards Lifesciences' culture. We help our teams achieve this mission by building safe, clean, and innovative workspaces so our people can feel effective with their work. As part of our Facilities team, we'll provide you with the resources needed to ensure you can keep our offices, plants, and facilities running smoothly so they may be a supportive and dynamic place to work. Your commitment to creating an effective and healthy working environment helps co-workers connect and feel engaged, allowing teams around the world to better contribute and focus their renewed energies on the patients we support. The Facilities Technician performs repairs and maintenance in plant or office facilities. How you'll make an impact: Perform all routine and non-routine, which include on-call and weekend work orders focusing on more complex employee moves, office set ups and changes for meetings, events, and conferences with high customer satisfaction while adhering to company standards Perform general repairs and maintenance in all the following: carpentry, plumbing, painting, electrical systems, in plant or office facilities with the ability to perform complex repairs in two or more specialties Conduct routine, periodic, or special inspections as required by the validated, electronic PM system while carrying out repair and maintenance work necessary to prevent breakdowns of facilities, machinery and equipment; Trouble shoot and diagnose controls and system failures Monitor and adjust building automation systems to optimize efficiency and energy savings while continuously referring to internal Quality documents and procedures to ensure compliance; collaborate with Quality in devising and implementing corrective actions, exception work orders (EWOs) Inspect and report issues noticed in interior and exterior spaces, including landscape Perform daily facilities PM (preventative maintenance) including production facility environmental support systems to ensure operations within specifications Obtain quotes and initiate purchase requests for maintenance and renovation work including discussing with contractor, vendor and/or consultant for minor projects Perform predictive maintenance inspection of critical facilities systems to detect abnormalities and prevent premature system failures Monitor inventory level and reorder to replenish supplies Analyze predictive inspection data of critical facilities systems to determine predictive maintenance actions to prevent premature system breakdown Review and analyze unplanned maintenance of facilities systems for root causes and implement corrective and preventive action for improvement as well as reviewing all equipment and determine spare parts list of facilities system Train, coach, and guide lower level employees May oversee and advise contractors (i.e. electricians) in general maintenance Monitor security of facilities and grounds including cameras, doors, and badge access May be the primary contact in absence of management Other incidental duties What you'll need (Required) : H.S. Diploma or equivalent and 3+ years of previous related experience with working knowledge in two or more of the related fields including plumbing, electrical, carpentry, and painting required Be available for overtime and on-call rotations (On-call allowance provided) What else we look for (Preferred): In depth knowledge and experience in HVAC system, Electrical system, and Compressed air system Good verbal and written communication and interpersonal skills Able to read, comprehend, speak, and write English Good computer skills, including MS Office and Internet Explorer required; facilities management systems (e.g., Blue Mountain, Alerton) preferred Full knowledge of routine preventive maintenance including carpentry, plumbing, painting and lighting repair Ability to use hand and power tools Ability to read and understand blueprints, sketches, layouts, wiring diagrams, drawings and specifications Ability to identify problems and relevant issues in complex situations, using specialized knowledge and propose solutions Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to general and controlled spaces Strict attention to detail Must be able to work with other departments including formulating work instructions and providing guidance and training to lower-level employees with little to no direction 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 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
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. The Inspector assesses devices in-process and upon completion, reviews accompanying documentation, and conduct audits to ensure all comply with regulatory and company guidelines, and that devices meet operational standards as designed. Working Hours: Monday to Thursday, 5:45am- 4pm Key Responsibilities: Perform visual, dimensional, and functional inspection on a wider variety of components and/or finished medical device products using a wide variety of tools and equipment such as magnifying lamp, microscope, vision inspection system, etc. to ensure conformance with design specifications while working at a level of greater independence with a higher level of productivity; Utilize a microscope in the inspection of equipment, in keeping with associated SOP; may also operate automated inspection equipment to verify dimensional requirements Perform functional testing of more complex finished medical device products using both automated and manual valve testing equipment to ensure conformance with design specifications Conduct operational audits and documentation reviews to ensure compliance with applicable procedures and documentation standards Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records and utilize a variety of computer programs to perform and/or document specific job tasks Provide core team feedback, including escalating work issues and changes in the final devices and raw materials to higher levels (e.g., Engineering Support) for assessment and correction Perform line clearance and verification of inspection Perform verification of manufacturing documents with component and device drawings Support the training of other inspectors through work demonstration and feedback May ensure smooth shift transitions by providing status de-brief of shift activities Participate in special projects, performing Test Method Validations (TMVs), protocols, first article inspection, etc. On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hour or longer work period Other incidental duties: General work area housekeeping Education and Experience: 2 years of previous related experience, including GMP and GDP Required H.S. Diploma or equivalent Preferred Additional Skills: Good communication skills Able to read, comprehend, speak, and write English Basic computer skills, required, including working knowledge of manufacturing software Strict attention to detail Adhere to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing Ability to use applicable tools and equipment, hand-eye coordination, and high manual dexterity Full understanding of applicable inspection procedures Continuously expands proficiency in inspection techniques Ability to clearly describe and convey nonconformance issues, and enter them into QMS (Quality Management System) Must be able to work in a team environment and with minimum supervision by following detailed work instructions Ability to effectively provide and accept feedback from colleagues 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 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Manufacturing Engineer position is a unique career opportunity that could be your next step towards an exciting future. The Manufacturing Engineer II applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes. How you'll make an impact: Improve manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement Develop basic experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyse results, make recommendations, and develop reports Analyse and resolve basic 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.) Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work What you'll need (Required): Bachelor's degree in an Engineering or Scientific Field and a minimum 2 years' experience in a similar role What else we look for (Preferred): Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable) Basic documentation, communication (e.g., written and verbal) and interpersonal relationship skills Basic understanding of statistical techniques Previous experience working with lab/industrial equipment preferred (if applicable) Good understanding and knowledge of principles, theories, and concepts relevant to Engineering Good problem-solving, organizational, analytical and critical thinking skills Good 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 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 immediate supervisor and other team members in the section or group; and may interact with vendors Ability to build stable working relationships internally 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 To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
