Senior Engineer, NPD Quality

Edwards Lifesciences•Irvine, CA

About The Position

Our New Product Development Quality team plays a central part in ensuring our products are delivered to patients with cardiovascular disease. You'll partner cross-functionally with Manufacturing, Clinical, Regulatory, and R&D teams, delivering thoughtful solutions to complex challenges while expanding your knowledge of the medical device industry.

Requirements

Bachelor's degree in Engineering or a Scientific field and 4 years of related industry experience; OR Master's degree or equivalent in Engineering or a Scientific field and 3 years of related industry or industry/education experience

Nice To Haves

Proven expertise using the MS Office Suite, including MS Project; CAD experience preferred (if applicable).
Strong documentation, communication (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 (if applicable).
Substantial understanding and knowledge of engineering principles, theories, and concepts relevant to the role.
Strong problem-solving, organizational, analytical, and critical-thinking skills.
Substantial understanding of the processes and equipment used in assigned work.
Good leadership skills and the ability to influence change.
Knowledge of applicable FDA regulations for the 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.
Ability to work effectively in a team environment, including inter-departmental teams, and to serve as a key contact representing the organization on contracts or projects.
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

Applying knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards systems/procedures for new product development.
Developing, updating, and maintaining design control documentation throughout the product development process; supporting the creation of design requirement documentation.
Developing, updating, and maintaining the technical content of risk management and usability files.
Collaborating with R&D, Manufacturing, and other cross-functional stakeholders to drive process and/or test method development, product builds, clinical programs, design transfer, and product launch; participating in design verification and validation testing.
Investigating complex product quality and compliance issues (e.g., pre-commercial complaints, CAPA, non-conformances, audit observations, PRAs) during new product development based on engineering principles; analyzing results, making recommendations, and developing reports.
Identifying and ensuring the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., Six Sigma, Lean) to support design for manufacturing and continuous process improvement; identifying opportunities for the design or redesign of equipment, tools, fixtures, and related components to improve manufacturing processes and/or test methods and reduce risk.
Assigning support tasks and providing instruction to technicians on conducting tests; training technicians and providing feedback; coordinating technician work as needed; and training, coaching, and guiding lower-level employees on routine procedures.
Performing other incidental duties as assigned.