Manufacturing Engineer II

• Apply knowledge of technical principles and Edwards systems/procedures to optimize manufacturing processes

• Optimize manufacturing processes using engineering methods (e.g. Six Sigma and Lean) for continuous improvement and/or the design/redesign of equipment tools fixtures etc. employing strong 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 nonconformances audit observations)

• Develop training and documentation materials (e.g. work instructions) to enable seamlessknowledge transfer of project and manufacturing processes

• Establish project plans to ensure deliverables are completed to customer expectations using project management tools (e.g. project plans risk analyses)

• Oversee manufacturing support tasks; provide instruction to technicians on conducting tests; train technicians offer feedback and coordinate technician work

• Perform other incidental duties as assigned by leadership

• Bachelors Degree in Engineering or Scientific field plus 2 years related experience

• Masters Degree or equivalent with internship senior projects or thesis in Engineering or related Scientific field includingeither industry or industry/education

• Proficiency with MS Office Suite including MS Project; CAD experience preferred (as applicable)

• Strong documentation and communication skills (written and verbal) with effective consultative and relationshipmanagement abilities

• Basic understanding of statistical techniques

• Prior experience working with laboratory or industrial equipment (as applicable)

• Solid understanding of engineering principles theories and concepts

• Strong problemsolving organizational analytical and criticalthinking skills

• Strong understanding of the processes and equipment used in assigned work

• Knowledge of and adherence to Edwards Environmental Health & Safety and Quality guidelines related to cleanroom medical device manufacturing

• Knowledge of applicable FDA regulations for the medical device industry

• Exceptional attention to detail

• Ability to interact professionally across all organizational levels

• Ability to manage competing priorities in a fastpaced environment

• Ability to work effectively in a team environment including managing vendors and project stakeholders

• Ability to build productive internal and external working relationships

• Commitment to adhering to all company rules and requirements (e.g. pandemic protocols Environmental Health & Safety rules) and taking appropriate measures to prevent injuries protect the environment and prevent pollution within their scope of influence and control

Aligning our overall business objectives with performance we offer competitive salaries performance-based incentives and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California the base pay range for this position is $87000 to $123000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g. qualifications education prior experience). Applications will be accepted while this position is posted on our Careers website.

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.