Senior Engineer, Manufacturing

Edwards Lifesciences•Irvine, CA

18h•Onsite

About The Position

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.

Requirements

Bachelor’s degree in Engineering or Scientific with a minimum of 4 years of manufacturing engineering experience in a highly regulated industry.
Onsite required.
Must have ability to travel up to 10%.

Nice To Haves

Class II and Class III medical device manufacturing experience.
Lean Six Sigma certification.
Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering as well as the production development process (PDP).
Experience with Windchill PTC.
Proven expertise in usage of MS Office Suite.
Effective communication and project management skills.
Strong analytical, problem solving, and technical writing skills.
Ability to work well independently based on minimal guidance.

Responsibilities

Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes (IQ/OQ/PQ/SWV/TMV); analyze results, make recommendations, and develop reports.
Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
Identify and ensure implementation of opportunities to optimize/improve manufacturing processes including using engineering methods (e.g., SIX Sigma and LEAN methods) employing technical design skills to re-design/design of and ensure equipment, tools, fixtures, etc are up to standards.
Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
Lead and establish project plans to ensure deliverables are completed to customer’s expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.).
Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
Perform other duties and responsibilities as assigned.