Edwards Lifesciences Sr Manager, Engineering - Implant Manufacturing (Irvine, CA) in Irvine, California
Manage a team of Quality Engineers and oversee the work of multiple manufacturing areas/value streams including product/process transfers, on-going commercial operations & continuous improvement, and new product/process/technology introduction/integration as required.
• Responsible for the review, execution/investigation, and approval of NCR & CAPA, Validations, EWO, Risk Management activities, and Quality System changes and updates. Includes identifying opportunities and leading implementation of process improvements by utilizing Lean methodology and Six Sigma Tools. Will be expected to lead, own, and coach teams through complex/uncharted issues and subsequent solutions (e.g. design or process related CAPA).
• Manage, mentor and motivate assigned team of Quality Engineers to achieve their potential, while meeting GSC & Quality commitments and project timelines. Develop a robust talent development plan in alignment with functional growth strategies of the department/Site. Responsible for the overall staff morale and culture for assigned areas and ensuring appropriate resources are allocated for on-going manufacturing operations, Plant/Site assigned projects, and product/process transfer activities (e.g. New Product Introduction/Launch and Manufacturing Site Transfer).
• Manage and/or oversee aspects of project activities with the accountability for successful completion of assigned deliverables related to the business objectives and Plant/Site project plans, schedule, and scope while applying engineering methods (e.g. Six Sigma & Lean methodology) to identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration and partnership with cross-functional groups.
• Influence and collaborate with cross-functional team members on strategic program activities and ensuring seamless transition and implementation of new processes and new product commercialization activities (e.g., VIP/value engineering, product engineering, process engineering, advanced engineering, core competencies)
• Establish/improve operating policies and procedures that affect department, subordinate sections, and work units/manufacturing value streams. Define requirements for validation activities of various manufacturing processes, equipment, and utilities and investigate/address any deviations or failures accordingly.
• Other incidental duties
Education and Experience:
Bachelor's Degree in a related field plus 10 years relative experience (or Masters Degree plus 8 years relative experience)
Experience in Quality Engineering, Quality Management, and/or Regulatory Compliance within the medical device or equivalent industry preferred
Demonstrated track record in management of technical and/or engineering disciplines required in regulated industry preferred.
•Expert understanding of engineering procedures/practices while addressing issues with impact beyond own team based on knowledge of related disciplines
•Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making – including global considerations throughout business network
•Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
•Expert understanding of process and equipment validation requirements and strategies (IQ/OQ/PQ/TMV)
•Expert knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO/EN standards)
•Expert understanding of Six Sigma methodology and tools such as design of experiments, process capability, FMEA, SPC, statistical methods and Lean Manufacturing
•Demonstrated ability to manage one or more teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
•Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality engineering to the business
•Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT
•Ability to interact with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications, leading briefings and / or technical meetings.
•Knowledge of domestic and international regulatory requirements (e.g., FDA, GMPs, and ISO13485/ISO14971/EN standards)
•Relevant Quality System Audit Experience (e.g., ISO9001 or ISO13485)
•Proven expertise in Microsoft Office Suite and related systems
•Adhere to all EHS rules and requirements 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
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.