Edwards Lifesciences Senior Manager, Engineering NPD - TMTT in Irvine, California
This is an exciting position within Irvine Pilot under Transcatheter the Mitral and Tricuspid Therapies (TMTT) business unit for those who like the challenge of new and breakthrough products. The Senior Manager, Engineering, will lead a team of engineers and technicians in the development of novel therapies for the TMTT group. In this role, the Senior Manager will be responsible for mentoring and coaching the team, guiding development through commercialization of new technology, interfacing with cross-functional partners through the product development process with End to End in mind.
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.
Perform other duties and responsibilities as assigned.
Bachelor's Degree in engineering with 10 years of experience with 3+ years of experience in a technical management role.
Medical device experience and familiarity with associated regulatory requirements.
Advanced degree is preferred.
Familiar with stent and delivery system/catheter design.
Technical understanding of manufacturing engineering, design for manufacturability, design and process excellence methodologies including Six Sigma, LEAN experience, cGMP, EH&S guidelines, supplier development and process validation.
Expert knowledge of design controls for Class II & III medical devices, including familiarity with one or more of the following: device sterilization, implantable NiTi, CoCr & tissue, electro-mechanical devices and catheter-based delivery systems.
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
Expert understanding of critical to quality (CTQ) design elements and cascading CTQs to design inputs / outputs and establishing process controls / limits.
Experience with development through commercialization process of medical devices.
Proven successful project management leadership skills.
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 work and excel within a fast paced, dynamic, and constantly changing work environment.
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.
Ability to explain complex concepts and strategies in understandable terms.
Ability to lead briefings and technical meetings for internal and external representatives.
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.