Engineer II, Supplier Development Engineering

Edwards Lifesciences • Irvine, CA

4d • Onsite

About The Position

Step into a role where your engineering expertise directly shapes the quality and reliability of life-saving medical devices by partnering with suppliers and cross-functional teams to solve complex challenges and drive meaningful impact for patients worldwide. Imagine how your ideas and expertise can change a patient’s life. Our Global Operations & Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You’ll partner cross-functionally with manufacturing operations and sales teams, delivering thoughtful solutions to complex challenges all while developing your knowledge of the medical device industry. Whether your work includes strategic inventory planning, labeling, warehouse management, material handling, or any of our other supply chain opportunities, you will be making a meaningful contribution to our team and to patients all over the world.

Requirements

• Bachelor's Degree in Engineering or Scientific field with 2 years experience required or Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education required.

Nice To Haves

• Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable).
• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
• Experience in the use of statistical tools (SPC, Six Sigma, DMAIC, etc.).
• Previous experience working with lab/industrial equipment required (if applicable).
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering.
• Solid problem-solving, organizational, analytical and critical thinking skills.
• Strong Project management skills.
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing.
• Knowledge of applicable FDA regulations for medical device industry.
• 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 the ability to manage vendors and project stakeholders.
• Ability to build productive internal/external working relationships.
• 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.

Responsibilities

• Responsible for ensuring the quality and reliability of components and materials sourced from suppliers.
• Working closely with suppliers to validate processes, improve sustainability, and address any quality issues that arise.
• Collaborating with various teams to develop and enhance components, ensuring they meet the required standards.
• Providing technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing.
• Participating in technical discussions with suppliers to identify and implement improvements in products and processes.
• Performing design and drawing reviews to ensure that components meet desired capabilities for manufacturing.
• Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier validations and Edwards receiving inspection fixture design for Test method validation.
• Responding with a high sense of urgency to quality issues and escalate / communicate appropriately.
• Ensuring that Tier 1 suppliers are using capable Tier 2 suppliers and resolving any inter-company conflict effectively.
• Strategically bringing various cross functional teams and suppliers in alignment on outstanding issues in a timely manner.
• Working with suppliers to optimize processes, reduce cost, ensure lean manufacturing as well as remove any waste from processes.
• Developing and managing project milestones in line with development and commercialization needs.
• Performing supplier risk & capacity assessment and taking appropriate actions to ensure timely and successful commercialization.
• Auditing suppliers for their technical capabilities as well as quality criteria.
• Perform other duties and responsibilities as assigned.

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level