Job description

The Transcatheter Heart Valve (THV) team is looking for a Senior New Product Development (NPD) Manager to support the development of our next-generation THV aortic delivery system. The Senior Manager will lead an early-phase development team in NPD as it grows through the product development lifecycle. The Senior Manager will have the opportunity to drive process design and characterization, work on a strong cross-functional team, and partner with the commercial site on process validations and commercialization activities.

Key Responsibilities:
Develop and execute a long-term strategy for deploying new processing technology and DFM solutions; partner with commercial manufacturing sites to develop new process technology.
Develop, communicate, and execute the strategy for the technical team to solve complex technical issues; guide the team in DFM and mistake-proofing activities.
Support the team in process development, characterization, and validations for Early Human Use, Clinical, and Commercial device release milestones using DMAIC methodologies.
Guide and implement validation strategies for the program to meet development project milestones as well as long-term product platform goals.
Promote knowledge sharing within the team and across teams/functions; actively develop engineering talent, act as a technical mentor, and acknowledge good work.
Represent the team to other internal technical partners as well as to business unit senior leadership.
Partner with Operations and Supply Chain at the Pilot and Commercial manufacturing sites for successful transfer and release of Clinical and Commercial device.
Perform other duties and responsibilities as assigned.

Required Qualifications:
Bachelor’s degree in Engineer with a minimum of 10 years of engineering experience in manufacturing/NPD/NPI.
A minimum of 5 years of experience in product and/or process development.
A minimum of 3 years of experience in a technical management role.
Proven successful project leadership skills.
Domestic and international travel is up 20%.
Must be on-site.

Preferred Qualifications:
Medical device industry experience is highly preferred.
Proven track record in product/process development; capable of articulating a strategy for progressing towards a loosely defined development goal.
Ability to foresee and manage risks within current projects and/or technology.
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.
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.
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.

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 $123,000 to $174,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

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.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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Disability accommodation for employment applicants
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Family and Medical Leave Act (FMLA)
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