Engineer II, Supplier Development Engineering

Edwards Lifesciences • Irvine, CA

4d • $85,000 - $120,000 • Onsite

About The Position

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. This opportunity will reside in the Transcatheter Mitral and Tricuspid Therapies (TMTT) Supplier Development Engineering team to provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease. You’ll make an impact by: Conduct engineering activities from the initial product development phase through product launch. Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing. Develop manufacturing technologies to meet new product demands. Support manufacturing readiness reviews, supply chain readiness reviews, and manage design transfers to production environment. Manage product phase in/phase out activities around design, regulatory and clinical requirements. Lead supplier validation activities (IQ, OQ, PQ), support milestone builds and commercialization of new product introduction. Integrate new products into manufacturing. Support supplier’s test method development and validation Conduct reviews to ensure DFM considerations are incorporated into designs. Assess and develop supplier part capability. Participate in technical discussions with suppliers to identify and implement improvements in products and processes. Perform 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 Lead recurring technical meetings with critical outsourced component/ assembly suppliers Respond with a high sense of urgency to quality issues and escalate / communicate appropriately. Ensure that Tier 1 suppliers are using capable Tier 2 suppliers and resolve any inter-company conflict effectively Strategically bring various cross functional teams and suppliers in alignment on outstanding issues in a timely manner. Work with suppliers to optimize processes, reduce costs, ensure lean manufacturing as well as remove any waste from processes. Develop and manage project milestones in line with development and commercialization needs. Perform supplier risk & capacity assessment and take appropriate actions to ensure timely and successful commercialization Audit suppliers for their technical capabilities as well as quality criteria. Perform other duties and responsibilities as assigned.

Requirements

• Bachelor’s Degree in Engineering or Scientific field, 2 years’ experience OR
• Master's Degree in Engineering or Scientific Field with internship, senior projects, or thesis in Engineering
• This role is required to be onsite. Selected candidate must reside within a reasonable commuting distance to Edwards campus in Irvine, CA.
• Up to 20% domestic/international travel.

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
• Basic understanding of statistical techniques
• 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
• Solid understanding of processes and equipment used in assigned work
• 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

• Conduct engineering activities from the initial product development phase through product launch.
• Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing.
• Develop manufacturing technologies to meet new product demands.
• Support manufacturing readiness reviews, supply chain readiness reviews, and manage design transfers to production environment.
• Manage product phase in/phase out activities around design, regulatory and clinical requirements.
• Lead supplier validation activities (IQ, OQ, PQ), support milestone builds and commercialization of new product introduction. Integrate new products into manufacturing.
• Support supplier’s test method development and validation
• Conduct reviews to ensure DFM considerations are incorporated into designs. Assess and develop supplier part capability.
• Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
• Perform 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
• Lead recurring technical meetings with critical outsourced component/ assembly suppliers
• Respond with a high sense of urgency to quality issues and escalate / communicate appropriately.
• Ensure that Tier 1 suppliers are using capable Tier 2 suppliers and resolve any inter-company conflict effectively
• Strategically bring various cross functional teams and suppliers in alignment on outstanding issues in a timely manner.
• Work with suppliers to optimize processes, reduce costs, ensure lean manufacturing as well as remove any waste from processes.
• Develop and manage project milestones in line with development and commercialization needs.
• Perform supplier risk & capacity assessment and take appropriate actions to ensure timely and successful commercialization
• Audit suppliers for their technical capabilities as well as quality criteria.
• Perform other duties and responsibilities as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees