Applies knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes.
Key Responsibilities:
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; analyze results, make recommendations, and develop reports.
Analyze 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).
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.
Incidental duties.
Education and Experience:
Additional Skills:
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.
Work is performed independently including comparing and evaluating possible courses of action after considering various possibilities.
Participates in arranging own activities in accomplishing objectives.
Contributes to the completion of sections of organizational projects and goals.
Failure to achieve results can normally be overcome without serious effect on schedules and programs.
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.
Develops solutions to a variety of problems of basic 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.