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BD recently completed the acquisition of the Edwards Critical Care business. This position is part of the Critical Care division, and as such, will become a part of the BD organization in the future. BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD at bd.com

Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.

Key Responsibilities:

• 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

• Incidental duties as assigned by leadership

Education and Experience:

Bachelor's Degree in in Engineering or Scientific field, 2 years years experience Previous experience working with lab/industrial equipment Required or

Master's Degree or equivalent in + internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education Required

Additional Skills:

• Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)

• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

• Basic (UT: Good) understanding of statistical techniques

• Previous experience working with lab/industrial equipment required (if applicable)

• 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

• Work is performed independently and reviewed upon completion for soundness in technical judgment, overall adequacy and accuracy

• Participates in determining objectives of assignment; arranges own activities in accomplishing objectives

• Contributes to the completion of more complex organizational projects and goals

• Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources

• 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

• Develops solutions to a variety of problems of moderate scope and complexity

• Contributes to process improvements

• Accountable to adhere to applicable Edwards Environmental, Health and Safety and Quality System requirements to ensure our products and services consistently meet customer and regulatory requirements.

• 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

• Ensure proper handling, storage and disposal of all waste generated in the facility according to applicable laws within the waste management program (RCRA). Prepare regulatory and/or internal reports, complete waste determinations, sign waste manifests and coordinate proper training sessions to affected personnel

Edwards 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.