Edwards Lifesciences Senior Manager, Engineering in Irvine, California
The primary responsibilities include the following:
Partner with Quality, R&D, Medical, Operations and Engineering personnel to identify linkage between CTQ’s, Critical Complaints and CCP’s. Ensure that a CTQ map (cascade) is robust and comprehensive for all Edwards product lines.Establish and drive end-to-end (E2E) GSC strategy, developing corporate and/or organizational policies to drive company growth and GSC Aspirations. Creates a culture for lean new product and process development and commercialization through collaboration with cross-functional partners and through the new product lifecycle driving design for manufacturing, robust process capability and integration of new technology.
Using the CTQ map, identify CCP’s necessary at all points in the value stream (Raw Material, Component Manufacturing, Assembly, Packaging/Labeling, Sterilization and Distribution).
Implement CCP’s that have the following characteristics:
Linkage to CTQ’s/Critical Complaints
Adequate Sampling Plan Rationales
Adequate Statistical Process Control
Adequate Mistake Proofing- Create a motivating and trusting environment where all personnel experience professional growth.
Drive results to measurably reduce Field Corrective Actions and Complaints through implementation of CCP’s.
Provides leadership and strategies for Continuous Improvement with the goal of increasing efficiency and driving down standard cost.
Drives the development of new and improved systems, processes, methods, equipment and technology in order to position GSC for growth, compliance and efficiency.
Uses proven and methodical approaches to problem solving to address complex technical issues across multiple disciplines.
Provides updates, strategy recommendations and plans to upper management as needed; Anticipates budget needs, quantifies budget to support budget planning, and manages budget.
Provides leadership and strategies across Plants to ensure a robust alignment and execution. Use excellent Change Management technique to ensure buy-in for use of CCP’s. Ensure compliance to FDA (21 CFR Part 11), EPA and other Regulatory Body standards objectives Responsible for reviewing and approving new equipment/processes (and significant changes).
Manage team to ensure smooth and continuous operations in engineering.
Plan and direct complex project activities with large scale or significant business impact with the accountability for successful completion of all project deliverables to the business and develop project plans and schedule, scope, and quality objectives. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues, etc. in collaboration with cross functional groups
Manage supervisors, managers, and/or experienced professionals and/or oversee the work of one or more areas, functionalities, and/or locations and have some budgetary responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department.
Lead cross-functional and/or departmental groups to develop and provide design recommendations that integrate into complex component(s) or product(s)
Lead efforts to optimize business processes and systems by assessing business needs and developing, proposing and implementing technology solution options.
Other incidental duties
Education and Experience:
Bachelor's Degree in in related field related experience in engineering and skill levels exceeding the requirements of the previous level Required and
Demonstrated track record in management of technical and/or engineering disciplines Required
Experience working in a regulated industry Preferred
Proven successful project management leadership skills
Proven expertise in both Microsoft Office Suite and related systems
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
Expert understanding of engineering procedures while identifying applications of functional knowledge and existing methodologies to complex problems
Expert understanding of related aspects of engineering processes and/or systems
Knowledge of financial acumen as it relates to engineering
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 influence cross-functional partners, business units, and/or sites and may engage with and influence senior management
Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of engineering to the business
Strict attention to detail
Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization
Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
Frequently interacts with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
Lead briefings and technical meetings for internal and external representatives
Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
Dedicated to quality client service and pro-active and responsive to client needs.
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions
Develop relationships and leverage them to influence change
Support and solicit input from team members at all levels
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 13,000 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.