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 Manufacturing Engineering role is a great opportunity to support the IHFM manufacturing team as we begin to set up operations in Irvine. In this role you will begin by setting up the distribution and servicing operations for one of our most recent acquisitions. Upon successful setup in Irvine, you will join the team responsible for transferring our first sensor manufacturing line to Irvine. You will also support the IHFM team by managing engineering activities such as new product introductions, stabilization activities, and commercial manufacturing.
How you'll make an impact:
As a member of Edwards' Pilot Operations team, you will help bring some of our most innovative new products closer to commercialization by partnering across business units and applying engineering expertise to improve manufacturability, process capability, and manufacturing readiness.
Apply technical engineering principles and Edwards systems and procedures to support, optimize, and sustain manufacturing processes within a pilot production environment.
Identify, recommend, and implement opportunities to improve manufacturing processes using Lean, Six Sigma, and other engineering methods, including the design, redesign, and qualification of equipment, tools, fixtures, and related manufacturing solutions.
Develop and execute complex experiments and tests, including authoring and executing protocols, to qualify and validate manufacturing processes; analyze results, make recommendations, and document findings in technical reports.
Analyze and resolve complex manufacturing and compliance issues, including CAPA, non-conformances, and audit observations, in alignment with quality and regulatory requirements.
Develop and maintain training materials and manufacturing documentation, including work instructions and procedures, to support consistent execution and effective knowledge transfer from project teams to production.
Lead and manage project plans to ensure deliverables are completed to customer expectations, using project management tools such as project plans, risk analyses, schedules, and related documentation.
Oversee manufacturing support activities by providing direction to technicians, supporting test execution, training team members, providing feedback, and coordinating day-to-day technician work.
Perform other duties as assigned by leadership to support Pilot Operations and evolving business needs.
What you'll need (Required):
Bachelor's Degree in Engineering or a related scientific field; 4 years of relevant experience; OR
Master's Degree or equivalent in Engineering or a related scientific field; 3 years of relevant experience; OR
Ph.D. or equivalent in Engineering or a related scientific field with relevant industry and/or academic experience.
Ability to travel up to 20% to Naperville, IL for product transfer activities
What else we look for (Preferred):
Demonstrated proficiency with the MS Office Suite, including MS Project; CAD experience preferred, where applicable.
Strong documentation, written and verbal communication, and interpersonal skills, with the ability to build effective consultative relationships with cross-functional partners.
Working knowledge of basic statistical techniques and their application in manufacturing and process validation environments.
Previous hands-on experience working with lab and/or industrial manufacturing equipment, as applicable.
Solid understanding of engineering principles, theories, and concepts relevant to manufacturing and pilot operations.
Strong problem-solving, organizational, analytical, and critical-thinking skills, with the ability to evaluate and resolve complex issues.
Thorough understanding of manufacturing processes and production equipment used within the assigned area.
Demonstrated leadership capabilities, with the ability to influence change and drive continuous improvement initiatives.
Knowledge of and compliance with Edwards Environmental Health & Safety (EHS) and Quality System requirements, particularly within clean-room medical device manufacturing environments.
Working knowledge of applicable FDA regulations and regulatory expectations for the medical device industry.
High attention to detail with a strong commitment to accuracy and quality.
Ability to interact professionally and effectively with employees at all organizational levels, including senior internal and external stakeholders.
Proven ability to manage multiple competing priorities in a fast-paced, dynamic environment.
Ability to work collaboratively in a team-based, cross-functional environment and represent the organization on projects or external engagements as needed.
Commitment to adhering to all company policies and requirements, including Environmental Health & Safety regulations, injury-prevention practices, and environmental protection and pollution-prevention measures within one's area of responsibility.
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 $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.
