Engineer II, Manufacturing Quality

Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.

Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How You'll Make An Impact:

• Leads investigation of 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.

• Identify and ensure the optimization of Manufacturing and/or R&D 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, MES, etc. to improve manufacturing processes, and reduce risk.

• Develop, update, and maintain technical content of risk management files.

• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes.

• Support Process Validation on Manufacturing Equipment (IQ/OQ/PQ) through review and approval of protocols and reports.

• Collaborates with R&D, NPD, Pilot, Manufacturing, Operations, and personnel at other Edwards Manufacturing facilities to support Tissue & Solutions Operations projects and activities.

• Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.

• Train, coach, and guide lower-level employees on routine procedures, root cause analysis, and quality system compliance.

• Other incidental duties assigned by Leadership

What You’ll Need (Required):

• Bachelor's Degree in Engineering, 2 years experience in medical device industry required or

• Master's Degree in Engineering, 1 year experience in medical device industry required.

What Else We Look For (Preferred):

• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

• 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

• 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

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.

For California, the base pay range for this position is $83,000 to $117,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).   Applications will accepted while this position is posted on our Career website.

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