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. Join us and be part of our inspiring journey.
The Director of Engineering role is a great opportunity to build and manage the IHFM manufacturing engineering team as we begin to set up operations in Irvine. In this role you will lead 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. Your focus will be to ensure smooth continuous operations and engineering activities with overall responsibility of developing systems, staffing, planning, budgeting, managing expense priorities, performance management, and working through managers to achieve results. Develop SMEs to ensure engineering knowledge continuity. Drive culture, engage staff morale, and ensure employees' safety. Develop robust talent development and succession planning in alignment with functional growth strategies across own organization.
How you’ll make an impact:
Develop and execute strategic plans to seamlessly transfer and qualify product designs into the supply chain and manufacturing operations, ensuring readiness, scalability, and sustained performance.
Partner closely with New Product Development teams to embed Design for Manufacturability (DFM) principles early in the development lifecycle, enabling robust, scalable, and cost‑effective solutions across the new product portfolio.
Drive continuous improvement initiatives by identifying, prioritizing, and executing opportunities to enhance manufacturing capability and performance using DFM, Six Sigma, and Lean Manufacturing principles.
Attract, develop, and retain top engineering talent, building strong succession plans and technical depth to meet current business demands and future growth objectives.
Oversee budgets, resource planning, and talent development, ensuring efficient utilization of resources and effective execution of business and operational objectives.
Proactively assessing and implementing strategies to ensure business continuity (e.g., material obsolescence, capacity limitation, master validation plans). Lead in identifying risk, developing complex mitigation strategies, defining alternative solutions, resolving issues, etc. in collaboration with cross functional groups.
Lead the integration of new products and collaborate with NPI and R&D teams on product and process transfers.
Drive a value stream mindset and culture of continuous improvement based on lean and Six Sigma principles.
What you’ll need:
Bachelor’s degree in engineering or scientific.
On‑site presence is required to effectively lead teams, collaborate cross‑functionally, and support manufacturing operations.
Proven experience leading, managing, and developing engineering teams, ideally within the medical device industry.
Willingness to travel up to 25%, both domestically and internationally, as required to support business and manufacturing needs.
What else we look for:
Class II and Class III medical device manufacturing experience is preferred.
Advance degree such as an MBA
Six Sigma Black Belt certification.
Demonstrated deep subject‑matter expertise in electronic engineering and manufacturing technologies, with the ability to apply technical knowledge to scalable, production‑ready solutions.
Strong business acumen, with a proven track record of developing and executing both strategic and tactical technical business plans aligned with organizational objectives.
Exceptional communication, negotiation, and presentation skills, with the ability to convey complex technical and strategic concepts and influence decision‑making at the highest levels of the organization.
Proven ability to establish and sustain strategic relationships with raw material and component suppliers, academic institutions, and external technology partners.
Demonstrated capability to manage complex technical programs and global supply chains, effectively balancing risk, priorities, and execution in fast‑paced environments with aggressive timelines.
Experience applying Six Sigma tools to solve complex technical challenges and leveraging Lean Manufacturing principles to develop robust, sustainable manufacturing processes.
Proficient in the Microsoft Office Suite, including MS Project, to support planning, execution, and communication of technical initiatives.
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 $159,000 to $226,000 (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.