Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives.
The Senior Quality Engineering role is a great opportunity to support the new IHFM Pilot operations team as we begin to set up operations in Irvine. In this role you will join the team responsible for transferring our first sensor manufacturing line to Irvine. You will also support the IHFM Pilot operations team by managing quality engineering activities related to new product introductions, stabilization activities, pre-commercial production and commercial manufacturing.
How you will make an impact:
Investigate complex manufacturing product quality and compliance issues (e.g., Material Review Board, CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to imprve manufacturing processes, and reduce risk.
Implement and monitor Critical Control Points.
Develop, update, and maintain technical content of risk management files (e.g. FMEAs, Quality Control Plans).
Develop, optimize and validate low complexity test methods and associated equipment. Support documentation of inspection methods for purchased components.
Collaborate with engineers for equipment selection and validation.
Develop training and documentation materials for production and Receiving Inspection (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.
Implement and approve compliant change control.
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Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Train, coach, and guide lower level employees on routine procedures
Other incidental duties assigned by Leadership
What you'll need (required):
Bachelor's Degree in Engineering or related field, 4 years’ experience related industry experience or
Master's Degree or equivalent in Engineering or related field, 3 years’ experience related industry or industry/education experience or
Ph.D. or equivalent in Engineering or related field, 0 years’ experience
What else we look for (preferred):
Proven expertise in usage of MS Office Suite; CAD experience
Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
Working knowledge and understanding of statistical techniques
Previous experience working with lab/industrial equipment
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
Strong problem-solving, organizational, analytical and critical thinking skills
Substantial understanding of processes and equipment used in assigned work
Good leadership skills and ability to influence change
Knowledge of and adherence to Quality systems
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
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
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 $108,000 to $153,000 (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.
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