Pilot Quality Engineer II Delivery Systems

Imagine how your ideas and expertise can change a patients 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. Youll bring your passion for problem solving and partner with various teams to influence decision-making for a products 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 youll need (Required):
Bachelors Degree in relative Engineering field plus minimum of two (2) years medical device industry experience or
Masters 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 $87000 to $123000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g. qualifications education prior experience). Applications will be accepted while this position is posted on our Careers website.

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