Sr Technologist, Packaging Lab

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 15, 2020

Job Description:

Job Description

Performs a wide variety of tasks in support of Engineering activities.

Key Responsibilities:

• SME (Subject Matter Expert) with in-depth knowledge and technical proficiency in support of the widest range of engineering activities such as test, modification, fabrication and assembly; including identifying potential improvement opportunities and proposing technical solutions to optimize products, processes, and/or equipment

• Build complex prototypes, sub-assemblies, and prepare feasibility test units and samples.

• Operate a wide range of lab equipment including set-up, clean-up, break-down, and re-assembly. Perform operational test and identify failure modes on systems and equipment and propose and implement technical solutions.

• Troubleshoot equipment failures and manage repair with equipment vendor or service providers

• Draft protocol and manage equipment IQ (Installation Qualification) and software validation

• Perform test method development and validation (TMV) for test equipment

• Collect, document, and analyze test data. May initiate ECRs (Engineering Change Request)

• Train, coach, and guide lower level employees on new procedures, assess work techniques and provide feedback to engineers on procedures

• Manage equipment Calibration and PM

• Draft new lab procedures (SOP), enhance current procedures, and initiate ECR to implement

• Other incidental duties as assigned by Management

Education and Experience:

• Associate's Degree or equivalent in technical degree/certificate

• 8 years previous experience in R&D Lab and/or medical device MFG, or 10 years related experience required

• Knowledge of Medical Device Packaging Validation(ISO 11607 & applicable ASTM) is a plus

Additional Skills:

• Excellent written and verbal communication, interpersonal, and relationship building skills with focus on influencing and conveying recommendations

• Must have problem solving methodology, root cause analysis, and GDP (Good Documentation Practices)

• Must have strong computer skills, including usage of MS Office Suite

• Must have extensive knowledge of equipment in a lab environment

• Ability to perform complex troubleshooting

• Ability to identify problems and relevant issues in complex situations, assessing using standard procedures and may propose solutions

• Ability to use a wider range of manufacturing, test, development or diagnostic equipment; use tools such measuring equipment

• Ability to read and understand procedures, drawings, schematics and carry out assembly instructions

• Knowledge and understanding of statistical techniques and procedures

• Ability to utilize CAD/drafting software (if applicable)

• Knowledge and understanding of ECR software systems

• Ability to draft technical documents (i.e. testing procedures)

• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to lab and/or clean room medical device manufacturing

• Strict attention to detail

• Must be able to work in, and may lead, inter-departmental teams, as well as with colleagues from other departments, in the exchange of information; represent organization to outside contacts, i.e., vendors and interact with contacts to convey technical opinions and recommendations to influence outcomes

• Ability to provide feedback in a professional, direct, and tactful manner, including guiding lower level employees

• Adhere to all EHS rules and requirements 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. SDL2017

Keywords: Edwards Lifesciences, Irvine , Sr Technologist, Packaging Lab, Other , Irvine, California