Provide technical manufacturing support to Operations and Solution Mixing area.
**Key Responsibilities**:
- Execute experiments and tests (following protocols) to develop findings for the validation and improvement of equipment and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports for Engineering review.
- Review documentation and take appropriate actions to ensure that information is appropriately catalogued and follow through to validation and qualification of equipment, including transferring information to appropriate locations, e.g., ECRs, SOPs, drawings, and tooling, for Engineering approval.
- Identify potential improvement opportunities and propose solutions to optimize equipment, e.g., re-design/design of basic equipment, tools, fixtures, for Engineering review.
- May lead small projects related to new equipment validation, equipment investigations, testing, objective evidence of product dispositions and rework.
- Utilize manufacturing software (e.g., JDE, QMS,PLM) to update SOPs documentation in systems.
- Provide coaching and guidance to technicians.
- Other incidental duties
Education
Technical degree/certificate in related discipline such as electric, mechanical, electronics, quality - productivity, and/or mechatronics, or related field.
Required
Experience
More than 3 years of previous experience in manufacturing and/or medical device experience.
Required
**Experience in supporting validation processes**: tasks related to make and review documentation for Engineering approval, and update standard operating procedure.
Required
**Additional Skills**:
- Good written and verbal communication, interpersonal, and relationship building skills.
- Ability to read, comprehend, write, and speak English.
- Good computer skills, including usage of MS Office Suite.
- Knowledge of validation and improvement of automated equipment.
About Edwards Lifesciences
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring.
Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 18,500 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work.
From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.
COVID Vaccination Requirement
**For United States Applicants Only**:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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