Pilot Quality Engineer II

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

The Engineer II, Quality will support the Advanced Catheter COE goal of leading robust pre-commercial design, manufacturing and characterization of advanced catheters. The engineer will work closely with R&D and Pilot engineering partners within the COE and the cross functional product teams to understand prototype design and product clinical use to setup and optimize scale-up ready and clinical capable manufacturing operations.

How you will make an impact:

• Develop Subject Matter Expert (SME) knowledge in Advanced Catheter Design, Manufacturing & Characterization.

• Identify, Support and Own implementation of opportunities to optimize manufacturing processes, test methods utilizing engineering methodologies (e.g. Six Sigma/DMAIC, LEAN).

• Design & execute engineering studies supporting design development, process characterization & test method development.

• Utilize data analysis tools to diagnose process and testing capability. Formulate recommendations and strategies to resolve issues related to unfavorable process trends and signals.

• Clear and consistent communication of data, trends and insights from engineering studies and manufacturing builds.

• Harmonize use of root cause analysis tools with hands-on engineering expertise to resolve process and testing challenges and to identify/control critical product failure modes and failure mode effects.

• Support transfer of pre-commercial manufacturing and characterization processes to commercial partners.

• Support deployment of automated inspection platforms and creation of automated inspection routines/workflows.

• Implementation of risk control methodologies (e.g. Critical Control Points, FMEA, Mistake Proofing).

• Support manufacturing tasks; give instruction to technicians and operators on completing operations and/or conducting tests; training of technicians and operations and coordination of workstreams.

• Evaluation of new technologies to support ongoing design, manufacturing and testing endeavors within the COE.

What you will need (required):

• Bachelor’s degree in Engineering or Scientific field of study required

• Minimum of 2 years of relative engineering experience required

What else we look for (preferred):

• Eagerness to positively disrupt historical practices and established systems for future improvement.

• Proficiency with statistical based software (Minitab, JMP).

• Proficiency in Materials Science fundamentals.

• Experience in a regulated production environment.

• Strong documentation, communication (e.g. written and verbal) and interpersonal relationship. skills including consultative and relationship management skills.

• Strong MS Office (Word, Power Point, Excel) skills.

• Ability to manage competing priorities in a fast-paced environment.

• Knowledge and understanding of medical device product development processes.

• Knowledge and understanding of quality systems and risk management.

• Able to travel up to 15%.

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 $81,000 to $114,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).   

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

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