New Product Development Quality Engineer II (TMTT)

Edwards Lifesciences • Camp Hill, PA

248d • $85,000 - $120,000

About The Position

Imagine how your ideas and expertise can change a patient's life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You'll bring your passion for problem solving and partner with various teams to influence decision-making for a product's entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology. In this role, you will apply your knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Requirements

• Bachelor's Degree in Engineering or Scientific field, 2 years' experience related work experience OR Master's Degree or equivalent in Engineering or Scientific field including either industry or industry/education.
• Experience with test method development and validation.

Nice To Haves

• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
• Experience with risk management documentations (i.e., RMW, DFMEA).
• Basic understanding of statistical techniques.
• Previous experience working with lab/industrial equipment required.
• 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 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 the ability to manage vendors and project stakeholders.
• Ability to build productive internal/external working relationships.

Responsibilities

• Develop and validate complex test methods (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports.
• Develop, update, and maintain technical content of risk management files.
• Work closely with R D and Clinical Development to collaborate on project deliverables and meeting timelines.
• Engage on design assurance and reliability related activities.
• Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
• Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma 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.
• 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.

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: Entry Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree