Position Title:

Senior Quality Engineer Work Location:

Irvine, CA 92614

Assignment Duration:

9

Months Work Arrangement:

Onsite Position Summary:

This Pilot Operations Senior Quality Engineer role partners on the validation activities for an introducer sheath for the Transcatheter Heart Valve (THV) Business Unit.

Background & Context:

Our Quality team helps shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. In this role, you will apply your

IQ/OQ/PQ

knowledge as well as quality engineering principles and methods to ensure compliance with regulatory requirements and our organization's systems/procedures to deliver much needed devices to patients.

Key Responsibilities:

Identify and ensure the optimization of complex Manufacturing processes using engineering methods (e.g., SIX Sigma, TOPP and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk. Review and approve equipment validations and asset management actions. Participate in validation strategy development and review the PVP/MVP. Ensure validation scope aligns with intended use, risk assessment, and regulatory requirements. Review PFMEAs and process risk assessments to verify critical process parameters (CPPs) and critical quality attributes are adequately addressed. Confirm prerequisite activities are complete (equipment qualification, TMV, software validation, fixture qualification, drawing release status, etc.). Verify statistical rationale, sampling plans, and acceptance criteria are appropriate. Develop, update, and maintain technical content of risk management files, review and revise pFMEAs in conjunction with BU PMS team Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work. Other incidental duties assigned by Leadership.

Qualification & Experience:

Bachelor's Degree in Engineering or related field, 4 years experience related industry experience Required or Master's Degree or equivalent in Engineering or related field, 3 years experience related industry experience Preferred or Ph.D. or equivalent in Engineering or related field, 0 years experience related industry experience Preferred Certifications CQE (Certified Quality Engineer), Six Sigma or Lean Blackbelt preferred Proven expertise in usage of MS Office Suite Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills Working knowledge and understanding of statistical techniques will be required for work related plant sites Previous experience working with lab/industrial equipment preferred Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering Strong problem-solving, organizational, analytical and critical thinking skills Substantial understanding of processes and equipment used in assigned work Good leadership skills and ability to influence change Knowledge of and adherence to Quality systems 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 inter-departmental teams and key contact representing the organization on contracts or projects Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations 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