Job description

Responsible for the development, manufacture, repair, maintenance and evaluation of tooling (including mold and dies) for the plastics processing areas. Applies skills and dexterity in the development of engineering prototypes, supports the improvement of products and processes and new product development, in keeping with SOPs and applicable regulatory guidance.

Key Responsibilities:
Perform a wide range of preventive and corrective maintenance to complex tooling/molds and related equipment, as required, including recording traceable information on device history records and may enter information into system (e.g., JDE, Maximo) as appropriate while applying knowledge of processes in the use of machines to ensure successful outcomes, as well as to devise process changes; formulate, propose and implement technical solutions.

Manufacture and/or modify a wide range of existing tooling/molds, fixtures and/or metal assemblies as required, using equipment such as manual and automated (Computational Numerical Control – CNC) bulk material removal machines (e.g., lathes, mills, grinders, drills, electric discharge machines) and welding equipment (micro-welding); propose technical solutions.

Determine optimal tool path for fabricating tools, provide technical solutions, and participate in product and tooling investigations for non-conformance issues as required.

Evaluate tooling/molds for product and process improvement or development; formulate, propose and implement technical solutions in partnership with cross-functional teams (e.g., Engineers).

Provide training, guidance, and feedback to advance the competence of other team members (e.g., Mold Makers) including new procedures and assessing work techniques.

Identify, discuss, escalate, and propose solutions on potential design issues.

Program, set up and operate all machines and perform CAD operations.

Collect, document, and analyze test data to propose solutions.

Other incidental duties.

Education and Experience:
Associate's Degree or equivalent in or technical degree/certificate , four (4) years experience previous experience in R&D Lab and/or medical device experience, required or

minimum six (6) years experience related experience, required.

Availability to work rotating shifts, holidays, and weekends.

Additional Skills:
Strong written and verbal communication, interpersonal, and relationship building skills.

Problem solving methodology, root cause analysis, and GDP (Good Documentation Practices).

Strong computer skills, including usage of MS Office Suite; and CAD if applicable.

Extensive knowledge of equipment in a manufacturing 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 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., manufacturing and 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.

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.

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 13,000 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

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice

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