This position will lead the Pilot Quality Operations function for TMTT and AIT programs as part of Global Supply Chain Pilot Manufacturing in Irvine. This position will lead a team of Pilot QEs that work with new product development teams in the manufacturing of products for feasibility/design verification studies, first-in-human/clinical builds and limited volume commercial manufacturing. This role also supports the product transfer from the Pilot Operations into commercial manufacturing facilities.

How you will make an impact:
• Direct supervision and development of a group of Quality Engineers. Oversee engineering tasks -provide technical guidance and feedback to engineers. Guide lower-level employees on complex procedures. Work on complex issues where analysis of issues requires in-depth knowledge.
• Plan and direct assigned operational and project activities with the accountability for successful completion of assigned deliverables. Oversee the development of project plans and timelines, identify risks and develop contingency plans to meet project objectives.
• Lead test method validation activities and Process FMEAs for Pilot Manufacturing lines. Support IQ/OQ/PQ for manufacturing equipment on the Pilot lines.
• Collaboration with R&D/NPD (New Product Development) to identify DFM opportunities and develop process/inspection characterization strategies. Partner with Commercial Operations and NPD to implement and sustain best practices across the manufacturing network.
• Identify opportunities and lead the implementation of changes to drive improvements in the development of robust processes that assure quality products and services. Track performance and perform quality trend analysis to drive continuous improvement.
• Drive Implementation of Critical Control Points on Pilot product manufacturing lines consistent with Edwards CCP methodology.
• Responsible for the decision of release/rejection/disposition of all products manufactured as part of the Pilot Manufacturing lines. Address product and process deficiencies through non-conformance and CAPA reports.
• Support product transfer from Pilot to commercial manufacturing sites.

What you'll need (Required):
• Bachelor's Degree in related field related experience in engineering
• Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device industry

What else we look for (Preferred):
• Experience working in a regulated industry
• Ability to manage technical and/or engineering disciplines and demonstrated informal mentoring and/or peer leadership skills
• Proven successful project management skills
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Engineering experience with medical devices and/or delivery systems
• People leadership for teams of 3+ direct reports
• Technical expertise in process development, statistics and/or software development/validation
• Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods
• Strict attention to detail
• Deep knowledge and experience using Lean and 6-sigma tools, Black Belt, preferred
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Develop relationships and leverage them to influence change
• Support and solicit input from team members at all levels within the organization
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
• Ability to develop and integrate metrics into projects and operations that clearly demonstrate the value of engineering to the business
• Knowledge of financial acumen as it relates to engineering

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 $121,000 to $171,000 (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.