Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey
How you will make an impact:
This is an exciting opportunity for an exceptional engineering professional with significant experience to join a team that is executing complex engineering and testing strategies for new innovative transcatheter mitral and tricuspid technologies. TMTT is dedicated to solving the unique challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives.
The Senior Director, R&D Engineering & Implant Testing is responsible for leading R&D activities including all aspects of implant testing for transcatheter mitral and tricuspid repair and replacement devices, (i.e. management of test labs, development of boundary conditions, development of new test methods and fixtures, and response to regulatory agencies) and supporting next generation product development activities. This leader will be responsible for partnering with cross-functional teams, colleagues in other Edwards business units as well as communication with outside regulatory agencies and physician partners. A strong candidate will have comprehensive knowledge and understanding of FDA and ISO guidance for structural heart implants, a strong understanding of test method development and strong project management skills.
Lead an R&D implant test organization which is expected to test sequential generations of the transcatheter mitral valve repair and replacement technologies.
Lead development of new test methods to meet the needs of the next generation designs and understand and changes in boundary conditions.
Work with project teams and testing engineers to understand and allocate resources to meet project timelines for feasibility testing activities, design verification testing, and commercial release testing.
Provide support as required for response to regulatory submissions and agency questions related to implant testing.
Focus on staff development, ethics and motivation through appropriate assignment of opportunities and training activities as needed to support achievement of both professional development goals as well as business goals.
Actively engage in development of staff performance management objectives (PMOs), ensuring deliverables are met on time and within budgeted cost parameters.
Manage budget spending for labs, CAPEX equipment and OPEX spending.
Work with Marketing teams and others to coordinate lab tours for physicians and other internal/external customers.
Manage quality, safety and environmental investigations and/or corrective actions for the lab space, perform non-conformance investigations for review with stakeholders, assure documentation content is valid, participate in improvement projects for laboratories.
Drive the adherence of individuals with lab access 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.
Collaborate with stakeholders (e.g. Facilities, Engineering) on managing and allocating space requirements within laboratory.
What you'll need (Required):
Bachelor's Degree in in related field related experience in engineering and skill levels exceeding the requirements of the previous level is required (Advanced degree in mechanical engineering is strongly preferred)
Demonstrated track record in management of technical and/or engineering disciplines in a medical device organization
Strong technical knowledge and execution skills with a demonstrated ability to test product concepts that are clinically usable
Direct prior experience with heart valve therapy products and catheter based interventional products inclusive of design as well as test protocol experience
What else we look for (Preferred):
Experience working with key opinion leaders and regulatory partners in the field
Strong interpersonal skills and people management skills. High emotional intelligence
Displays broad perspective and effective judgment, demonstrates well-reasoned problem solving and decision-making
Builds a shared vision; inspires others to action; sets clear direction; establishes plans consistent with that direction
Demonstrates a sense of urgency; understands the importance of outperforming and outpacing the competition in meeting customer and patient needs
Ability to work in a matrix organization and lead cross functional teams
Provide leadership and direction to large 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 within the organization
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) 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
The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Don’t miss your chance to be part of a dynamic, challenging, and rewarding environment!
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, the base pay range for this position is $182,000 to $259,000 (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.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.