Quality Engineer II - Pilot Quality Engineering

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Key Responsibilities:

• Work with NPD and PILOT Valve and Systems teams (and/or Accessories) to help them efficiently navigate the Edwards' Quality System in order to build quality system test samples and clinical human use product according to project schedules
• Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
• Participating in the identification and ensuring implementation of opportunities to optimize/improve Valve / system manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) to drive continuous improvement and mistake proofing activities
• Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Live Manufacturing Process Reviews)
• Implement/monitor Critical Control Points in the manufacturing process and formulate reaction plans to pre-derived process alert limits
• Execute test method validation activities for in-process and PV inspections
• Participate in Material Review Board to disposition potentially non-conforming human use products
• Lead inspector training and certification for delivery systems
• Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvements
• Pairing with plant network to ensure smooth transfer of production lines and implementation of best practices for manufacturing (e.g. Design for Manufacturing principles).
  
  

Education and Experience:

• Bachelor’s Degree in engineering or Scientific field with 2 years related work experience Required or
• Master's Degree or equivalent and internship, senior projects or thesis in Engineering or Scientific field with including either industry or industry/education Required
  
  

Additional Skills:

• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Quality systems
  
  

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 (CA), the base pay range for this position is $85,000 to $120,000 (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.