Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.
This Engineer II will support the Draper site's digital functionality with their primary focus on the Manufacturing Execution System or MES. This individual will support the day-to-day operations of all commercial lines within the site, new product rollouts, and enhancements or improvements to the existing models.
How you'll make an impact:
- 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
- Other incidental duties assigned by Leadership
What you'll need (Required):
- Bachelor's Degree in Engineering or Scientific field with 2 years experience OR
- Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education
What else we look for (Preferred):
- Medical device industry experience
- Good computer skills in usage of MS Office Suite including MS Project; CAD experience
- Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
- Basic understanding of statistical techniques
- 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
- Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
- 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
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.