Sr. Quality Engineer, NPD - IHFM

Edwards Lifesciences•Irvine, CA

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. Join us and be part of our inspiring journey. We are looking for a strong engineer with solid technical expertise, who enjoys working in a fast-paced and rapidly growing environment where taking initiative and collaborating cross-functionally are critical for success. The engineer will have a variety of responsibilities in New Product Development providing Quality Engineering support and leadership to ensure the successful design and development of new products.

Requirements

Bachelor's Degree in Engineering or Scientific field, 4 years’ experience including either industry or industry/education or
Master's Degree or equivalent in Engineering or Scientific field, 3 years’ experience including either industry or industry/education or
Ph.D. or equivalent in Engineering or Scientific field with industry experience or industry/education

Nice To Haves

Current or prior experience within Medical Device industry
Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation
New Product Development experience from initial concept to commercialization (Class III preferred).
Experience with Risk Management and Design Control
Working knowledge of the Domestic and International regulatory requirements of Medical Device regulations
Proven expertise in usage of MS Office Suite including MS Project
Advanced understanding of statistical techniques
Strong problem-solving, organizational, analytical and critical thinking skills
Quality Engineering experience in New Product Development is preferred
Strong documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills
Ability to prioritize, plan, and evaluate deliverables to established strategic goals
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 inter-departmental teams and key stakeholders representing the organization on projects
ASQ Certified Quality Engineer (CQE), Quality System Lead Auditor, Certified Six Sigma Black Belt (CSSBB), or related quality/regulatory certifications a plus

Responsibilities

Provide technical leadership for successful new product development projects by applying design control and risk management principles to positively influence new product development efforts from concept through product launch including design verification, validation, and design and manufacturing specification development.
Partner and collaborate with cross-functional stakeholders and peers on new product development teams to align on goals and drive actions to meet commitments.
Lead development and drive updates to risk management files for new products.
Lead test method development and validation activities for new designs.
Lead development and implementation of inspection and testing mechanism for components, sub-assemblies, and final assemblies used in new product design and manufacturing.
Develop technical solutions to complex problems, recommend and implement corrective actions, using creativity, statistical techniques, and reliability engineering.
Collaborate with manufacturing and operations team to ensure successful transfer and launch of robust products.
Managing/overseeing the work of an assigned team of direct reports within own function.
Developing a robust talent development plan in alignment with functional growth strategies of the individual and the department.
Ensure compliance with all Federal, State, local and company regulations, policies and procedures.
Performs other incidental duties as assigned by management.