Job Description

Oversee employees and daily operations within metrology.

Key Responsibilities:

• Supervise metrology staff for operations (e.g. process and implement of new/change work order requests for assets, PM, calibration and EWO) and oversee laboratory related activities (e.g., testing, inventory ordering/management, calibration, validation, maintenance of equipment and budget/cost control for assigned area), while establishing objectives in support of the company\'s strategy for the department.
• Lead complex improvement projects (e.g. Lean, Six Sigma, Business Excellence projects) in cost reductions and process efficiencies (e.g. waste, reduce product defects, and equipment process enhancement).
• Perform ad-hoc WO intervention for unscheduled maintenance and calibration, and maintain metrology system for all assets, PM schedules, job plans and routes.
• Partner with vendors/teams for calibration/FAI capabilities and requests to support calibration assignment and scheduling with vendors and custodians.
• Oversee the calibration and assist maintenance of all manufacturing equipment, minimizing equipment down time, optimizing equipment utilization, and ensuring appropriate safety procedures are carried out.
• Evaluate equipment feasibility study, process development and equipment validation and revalidation activities, while collaborating with key stakeholders.
• Ensure that technicians are trained and proficiently supporting manufacturing according to updated SOPs and adhere to GMP, GDP and safety requirements.
• Other incidental duties

Education and Experience:
Bachelor\'s Degree in in Engineering or Scientific field, 4 Years years experience of previous experience including in metrology/manufacturing role with skill levels exceeding the requirements of the Supervisor II Required
Medical device industry experience Preferred

Additional Skills:

• Strong technical background with exposure to equipment preventive and predictive maintenance activities, equipment enhancement and troubleshooting.
• Experience in project management, SPC, Lean and Six Sigma Principles
• Good understanding in calibration principles and standards such ISO/IEC 17025:2005
• In-depth understanding of procedures as it relates to assigned area of a laboratory environment
• Full knowledge of GMP, GDP and Health and Safety regulations
• Substantial knowledge of related laboratory equipment
• Proven leadership ability, including the ability to supervise/lead employee teams, coach and mentor lower lever supervisors, and effectively provide performance feedback.
• In depth analysis and problem solving in cases without clear precedent
• Experience leading and fostering multi-cultural teams with cultural sensitivity
• Proven project management expertise
• Proven expertise in both Microsoft Office Suite and Enterprise Resource Planning (ERP) system, preferably JDE
• Strict attention to detail
• Ability to interact professionally with internal customers and cross functional teams
• Ability to work in a fast-paced environment
• Must be able to work with cross-functional teams as well as with colleagues from other departments, interacting daily with subordinates and/or peers within similar and/or related functions
• May represent the organization to outside contacts (e.g., vendors, suppliers, contractors, staffing agencies)
• 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
• Travel (day and overnight by car, air, train, etc.) will vary. Percentage of time is determined by Management

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\xe2\x80\x99s 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\xe2\x80\x99s our life\xe2\x80\x99s 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.
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