Edwards Lifesciences Senior Manager, R&D Testing in Irvine, California
We’re looking for engineers with HEART . At Edwards Transcatheter Mitral and Tricuspid Therapies (TMTT), we are guided by our vision to lead and transform treatment for patients with mitral and tricuspid heart valve disease.
True to our patients-first focus, TMTT’s new product development (NPD) engineers puts their whole hearts into meeting the needs and improving the lives of this largely underserved patient population. The anatomies and clinical challenges that exist among patients with mitral and tricuspid valve disease are varied and complex, and we are committed to the development of a portfolio of therapies that transforms treatment and provides world-class outcomes.
Our mission is not for the faint of heart, or for those who prefer to go through the motions. As agile-minded trailblazers, our TMTT R&D Engineering team is constantly pivoting and problem-solving to deliver the most effective therapies possible, because it’s not about us or our design ideas, it’s about developing the right solution to meet the needs of the patient.
So, if you’re an exceptional Engineering professional with significant experience and a heart for solving complex challenges, join our team and help us improve patients’ lives through the development of transcatheter mitral and tricuspid therapies from the ground up.
As an integral part of the R&D team and closely involved in the NPD process, the Senior Manager, Engineering – Implant Testing will be responsible for the Repair Implant Testing Team and the development of test methods for characterizing and testing current, next generation and emerging mitral and tricuspid heart valve repair devices.
Essential Job Functions
Oversee all implant testing across generations including hydrodynamic, wear, and fatigue testing.
Develop innovative testing strategies for assessing efficacy of next generation implants as compared to existing generation.
Develop a robust talent development plan in alignment with functional growth strategies of the department, including mentoring engineers and technicians in developing robust and repeatable test methods using engineering principals.
Provide support during product investigations for Implant and metals related issues. Lead in identifying risk, developing mitigation strategies, uncovering alternative solutions, resolving issues, etc. in collaboration with cross functional groups.
Plan and manage a team of engineers and technicians including budgetary responsibilities.
Review Design Verification plans, protocols and test reports for all required implant testing, including test method development and validation.
Lead cross-functional and/or departmental groups to develop material lifelines for implant components.
Lead cross-functional efforts to optimize business processes and systems by assessing business needs and developing, proposing and implementing technology solution options.
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.
Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or an Engineering discipline
12+ years of experience in product development in a regulated industry, at least 5 years of which must be in the medical device industry (with a Masters - only 10+ years, with a PhD - only 8+ years)
2+ years of experience in implant testing
2+ years of experience managing product development teams
Proven ability to apply technical knowledge and judgement to complex technical problems
Proficient in Microsoft Office Suite products (Word, PPT, Excel)
Excellent written and verbal communication skills
Proven successful project management leadership skills
Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
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
Ability to influence cross-functional partners, business units, and/or sites and may engage with and influence senior management
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
Lead briefings and technical meetings for internal and external representatives
Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness
Able to develop test fixtures using CAD
If you have the heart to join us in our mission to help shape the development of mitral and tricuspid therapies that will transform treatment for millions of patients in need, apply now. Don’t miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate.
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.