Pilot Quality Engineer II - Delivery Systems

Edwards Lifesciences; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences in California is seeking a Pilot Operations Quality Engineer II to drive quality operations for pilot manufacturing and to lead compliance activities across the product lifecycle. The role focuses on implementing quality systems and processes to ensure patient safety and regulatory compliance.

The position collaborates with TMTT and development teams to produce test samples, support feasibility studies and early human use, and manage product transfers to receiving

Qualifications

• Requires a Bachelor’s degree in an engineering field plus 2+ years medical device experience.
• Master’s degree in engineering plus 1 year medical device experience.

Responsibilities

• Interact with multiple departments to achieve quality goals focused on Pilot manufacturing operations.
• Support new product development teams to navigate Edwards’ Quality System for test samples and human-use products.
• Review and approve equipment validations and asset management actions.
• Lead process improvements using SIX Sigma, TOPP and LEAN methods to reduce risk and improve manufacturing.
• Develop training and documentation for production to enable knowledge transfer.
• Perform risk assessments on early-stage manufacturing processes and drive improvements.
• Lead test method validation activities for in-process inspections and oversee product release.

Skills

Quality system knowledge

Problem solving

Data analysis

CAPA handling

Risk assessment

Training documentation

Cross-functional teamwork

Manufacturing process optimization

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Tools

MES

Job description

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 Edwards’ 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 enable you to optimize product development to impact patients around the world with pioneering technology. This Pilot Operations Quality Engineer II role will (1) interact with various functional departments to accomplish compliance and implementation of quality goals with a primary focus to lead quality operations for Pilot manufacturing, (2) work with TMTT new product development teams in the manufacturing of products for feasibility studies, quality system test samples, Early Human Use, and clinical studies as well as (3) support product transfer from Pilot manufacturing to receiving site manufacturing facilities.

How you will make an impact:

• Partner with Israel team members during reoccurring 7am meetings
• Work with new product development teams to help them efficiently navigate the Edwards’ Quality System to build test samples and human use product according to project schedules
• Review and approve equipment validations and asset management actions
• Optimize moderately 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
• Develop training and documentation materials for production (e.g., work instructions) to enable 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
• Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of manufacturing processes
• Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Manufacturing Process Reviews)
• Drive improvements for inspection methods; Lead test method validation activities for in-process inspections
• Oversee product release, assess and disposition product on-hold (MRB), and manage material quality control
• Investigate moderately complex manufacturing product quality and compliance issues (e.g., non-conformances, CAPA, audit observations) for production processes prior to final product release based on engineering principles: analyze results, make recommendations and develop reports
• Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvements

What you’ll need (Required):

• Bachelor’s Degree in relative Engineering field plus minimum of two (2) years medical device industry experience or
• Master’s Degree in relative Engineering field plus minimum of one (1) years medical device industry experience

What else we look for (Preferred):

• CQE (Certified Quality Engineer)
• Prior experience in medical device manufacturing or operations
• Electrical inspection experience preferred (e.g., resistance, continuity, hi-pot testing)
• Experience with computerized Manufacturing Execution System (MES)
• Strict attention to detail
• Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• 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
• Ability to manage competing priorities in a fast-paced environment
• Thrives in a collaborative team environment, including inter-departmental teams and key contact representing the organization on contracts or projects

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 (CA), the base pay range for this position is $87,000 to $123,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.